Clinical trial NCT04707625
Conditions: Retinal Vein Occlusion
Keywords: Vision Loss Eye Injections
Sponsor: Wake Forest University Health Sciences
Start date: 2021-10-06; Completion date: 2023-12-18
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to treat patients with retinal vein occlusion with standard of care anti-vascular endothelial growth factor therapy and to correlate levels of vascular endothelial growth factor in the anterior chamber fluid of the eye. This study will evaluate if measuring the vascular endothelial growth factor will help predict the timing of when anti-vascular endothelial growth factor therapy will be needed.

Detailed description:
Ten patients, 5 with branch retinal vein occlusion and 5 with central retinal vein occlusion, will receive stand of care anti-vascular endothelial growth factor over the course of 52 weeks while undergoing a paracentesis prior to each treatment. During the paracentesis anterior chamber fluid will be removed to evaluate vascular endothelial growth factor levels along with other cytokines present in the anterior chamber fluid. Ocular coherence tomography will also be collected at each visit to evaluate macular thickness which will be used to help determine treatment windows along with levels of vascular endothelial growth factor. Patients with high levels of vascular endothelial growth factor and the presence of macular edema on ocular coherence tomography will be treated every four weeks. Once vascular endothelial growth factor levels are reduced along with improvements of macula edema treatment windows will be extended to 8 weeks and then to 12 weeks once levels are normal and edema is no longer present.

Arms: arm 1: All subjects will receive aflibercept every 4 weeks. Once vascular endothelial growth factor levels become normal and macular edema improves treatment windows will be extended up to every 12 weeks.
Interventions: intervention 1: Aflibercept Ophthalmic
Intervention descriptions: intervention 1: Anti-vascular endothelial growth factor intraocular injection

Protocol documents:
Prot_SAP_001.pdf: 
VEGF Levels in RVO
IRB00064405
IRB Approval Date 01FEB23


1 
Study Title: Correlation of Vascular Endothelial Growth 
Factor Levels in Anterior Chamber Fluid to Disease State in 
Patients with Retinal Vein Occlusion Receiving Standard of 
Care Treatment 
Principal Investigator -  Mark H. Nelson, MD MBA, Assistant    
Professor of Ophthalmology, Wake Forest Baptist Health 
Co-Investigator: Rebecca Sappington, PhD, Associate 
Professor of Neurobiology and Anatomy, Vice Chair of 
Research, Department of Ophthalmology, Wake Forest 
Baptist Health. 
Co-investigator: Sally S. Ong, MD Assistant Professor of 
Ophthalmology, Wake Forest Baptist Health 
Co-investigator: Joseph Rigdon, PhD, Department of 
Biostatistics and Data-Science, Wake Forest Baptist Health 
Sponsor or funding source: Wake Forest Baptist Health: 
Surgery Ophthalmology  
Background, Rationale and Context 
     Retinal vein occlusion (RVO) is the second most common retinal vascular 
disease after diabetic retinopathy. It presents as a Branch retinal vein 
occlusion (BRVO) or a Central retinal vein occlusion (CRVO). The BRVO is four 
times more common as a CRVO. The pathophysiology of RVO involves the 
intraluminal thrombus formation, which may be associated with systemic 
conditions such as hypertension, hyperlipidemia, diabetes and abnormal 
thrombophilia. The blockage of venous circulation causes an elevation of 
intraluminal pressure in the capillaries, leading to hemorrhages and leakage 
of fluid within the retina. There is associated reduction of retinal perfusion as 
well, which leads to the secretion of vascular endothelial growth factor 
(VEGF). VEGF therefore has a leading role in RVO and leads to the clinical 
finding of macular edema which limits vision. The current treatment for RVO 


 
2 
 
is anti-VEGF therapy, injected into the vitreous, which has largely replaced 
macular photocoagulation. Randomized controlled trials (VIBRANT for BRVO 
(1) and  GALILEO/COPERNICUS (2, 3) for CRVO) have shown efficacy and safety 
with aflibercept (Eylea) injections. It would be advantageous to be able to 
measure VEGF  since our RVO treatment paradigms depend on initiating 
therapy with anti-VEGF drugs, as well as maintenance therapy which 
continues to suppress its production.  
      
     The purpose of this project is to treat patients with RVO with standard of 
care anti-VEGF drug Eylea (aflibercept)  and to then correlate levels of VEGF 
in the ocular fluids to disease state manifested by retinal, specifically macular,  
thickening, which can be objectively measured by Optical Coherent 
Tomography (OCT). The VEGF levels will be measured by ELISA, a laboratory 
test which will be performed by Dr. Sappington. i.e.In addition, further 
evaluation into the cohort of patients (10%) who have persistent exudation or 
who require monthly Eylea will be studied.  ELISA multiplex will be run 
simultaneously with the VEGF analysis to evaluate other proteins in the ocular 
fluids of patients with RVO in order to determine if other classes of cytokines 
are simultaneously responsible for the pathophysiologic exudative process 
found in RVO.           
 
Study Goal and Objective 
      
     The study hypothesis is that measuring VEGF levels from anterior chamber 
samples from paracentesis prior to Eylea (aflibercept) injections will create a 
improved paradigm for treatment which currently looks at OCT measurements  
of foveal thickness and the number of injections.   
 
Overview of Study Design       
      
     Patients will receive standard of care intravitreal injections of Eylea 
(aflibercept) over the course of 52 weeks while undergoing a pre-treatment 
paracentesis at each study visit. Anterior chamber fluid removed from the eye 
during the paracentesis will be used to measure VEGF levels as well as other 
cytokines.  
           


 
3 
 
     The anterior chamber fluid taken at each visit will be divided for both the 
ELISA VEGF analysis immediately and a portion to be frozen for further 
cytokine analysis in the future. 
      
     All study activities will occur at Wake Forest Baptist Health Highland Oaks, 
an outpatient clinic that is part of the Department of Surgery Ophthalmology,  
expect for the ELISA which will be done in a lab located at the Medical Center 
by Dr. Sappington. 
      
Methods and Study Design 
      
1. Recruitment and Consent      
     Recruitment will occur in an outpatient Ophthalmology clinic as patients 
are receiving eye exams for ocular related issues. Patients that are diagnosed 
with BRVO or CRVO will be asked by the Principal Investigator if they are 
interested in learning more about a research study related to their diagnosis. 
Patients that show interest will be presented with the study consent and the 
study will be reviewed with the patients. During this time patients will be 
provided time to review the consent and discuss the study with their families, 
friends or health care providers. Questions will be answered and any concerns 
will be addressed prior to obtaining consent. Patients will be informed that if 
they decide not to participate they will still receive treatment for any eye 
related issues. Other treatment options will be discussed with the patient by 
the Principal Investigator. 
 
    Patient data will not be collected for study related purposes until informed 
consent is obtained. Any data used to contact potential subjects prior to 
obtaining consent will be maintained in the electronic medical record.      
 
 
2. Screening 
     Informed consent will be administered prior to any study related activities 
being performed.  
      
     During the screening phase medical history will be reviewed to determine 
eligibility. All eligibility criteria must be met before a patient can move forward 
with study treatment and testing of VEGF levels.  


 
4 
 
      
     Patients that do not meet enrollment criteria (screen-failed patients) will 
be offered standard of care treatment. 
      
3.Treatment Period and Visit Schedule 
     Study assessments, procedures and standard of care treatment will be 
started on Day 1 for patients successfully enrolled into the clinical trial and 
continue through week 52.  
      
     If a patient is experiencing an ocular issue they will be instructed to 
contact the study doctor to determine if an additional follow up visit is needed.  
 
     The study will end at week 52. There will a need to continue treatment 
since anti-VEGF drugs are not a cure. This indefinite period where Eylea is 
continued will not be paired with saving  anterior chamber samples.  
      
4. Subject Selection Criteria      
     This is a non-randomized exploratory pilot study that will enroll 
approximately 20 subjects; 10 subjects with BRVO and 10 subjects with 
CRVO.  
      
Inclusion Criteria: 
1. Willingness and ability to provide written informed consent 
2. Age ≥18 years 
3. Diagnosis of Retinal Vein Occlusion with macular edema and central 
foveal thickness of ≥300 microns confirmed by intravenous fluorescein 
angiography and Optical Coherence Tomography 
4. Visual Acuity between 20/25 and 5/200 
      
Exclusion Criteria: 
1. Bilateral Retinal Vein Occlusion 
2. Vision worse than 5/200 in study eye. 
3. History of myocardial infarction, ischemia, or cerebrovascular accident 
within 6 weeks of screening  
4. Concurrent Proliferative Diabetic Retinopathy and/or Maculopathy 
5. Concurrent Exudative Age-related Macular Degeneration 


 
5 
 
6. Concurrent optic neuropathy with the presence of an afferent pupillary 
defect 
7. Previous vitrectomy in the study eye 
8. Currently pregnant or planning to become pregnant during the duration 
of the study. Women currently breastfeeding are also excluded  
9. Previous treatment for retinal vein occlusion in the study eye 
10. 
Any current medical condition which, in the opinion of the 
investigator is considered to be uncontrolled 
11. 
History of allergy or hypersensitivity to study treatment, 
fluorescein, or any study procedure and treatment related ingredients 
(e.g. topical anesthetics, betadine, etc.)  
12. 
If any of these conditions start after the initiation of the study, 
the patient will not be allowed to participate in the study, however, will 
be offered the treatment as described above.  
      
      
5. Study Treatment 
     The recommended dose of aflibercept for the treatment of RVO is 2mg (0.05 
mL). All subjects will be administered an intravitreal injection of 2mg (0.05 mL) 
aflibercept in a single-dose pre-filled syringe. All intravitreal injections will be 
performed by the Principal Investigator. 
      
 
      
6. Study Assessments and Procedures 
     During the screening phase, after consent has been obtained, a complete 
medical history, including clinically significant diseases, chronic and ongoing 
conditions, and all current medications will be collected. 
      
     Blood pressure will be collected prior to the paracentesis and intravitreal 
injection.  
      
    Ocular assessments will be performed on both eyes at each study visit and 
will include: 
1. Best Corrected Visual Acuity (BCVA) will be assessed using Snellen 
charts. If a subject’s visual acuity is so poor that the subject can’t see 


 
6 
 
any letters on the charts, finger counting and/or hand motions will be 
checked.  
2. Intraocular Pressure (IOP) will be measured prior to the paracentesis. 
IOP will be measured in both eyes with the results in mmHg. 
3. Slit lamp biomicroscopy will be performed to examine the eye 
structures for both eyes. The slit lamp exam will be performed prior to 
the paracentesis, and will evaluate lids, lashes, lens, conjunctiva, 
cornea, anterior chamber, pupils, cataract status and vitreous.  
4. Dilated indirect ophthalmoscopy will be performed to examine the 
retina of each eye after the pupils have been sufficiently dilated. The 
dilated indirect exam will occur prior to the paracentesis, and will 
evaluate the retina vessels, macula, fovea, periphery, optic nerve and 
vitreous.  
5. Optical Coherence Tomography will be performed prior to the 
paracentesis on both eyes, and will be assessed to determine the 
central foveal thickness. 
      
     A paracentesis will be performed at each study visit prior to anti-VEGF 
treatment. A topical anesthetic such at lidocaine, will be applied to the eye 
prior to the paracentesis.  A lid speculum will be inserted under the eyelids to 
hold the eye open during the paracentesis and the intravitreal injection. An 
application of betadine solution will be applied to the inferior sclera where a 
30 gauge needle attached to a syringe will be injected into the eye to remove 
0.1mL of anterior chamber fluid. Following the paracentesis, while the 
speculum is still in place, the intravitreal injection of aflibercept will occur. 
Directly following the intravitreal injection, betadine will be applied to the 
injection site to minimize the risk of infection. The samples will be divided in 
the clinic. All anterior chamber fluid samples will be stored until ELISA 
analysis has been completed.            
     Lab personnel will be present in the clinic at the time of collection. Upon 
collection, samples will be immediately placed on dry ice in an appropriate 
transport container. Samples will be immediately transported to 4087 Gray 
Building on WFBMC campus by the on-site lab personnel. Samples will be 
transferred from the storage container to the -80 degree freezer located in 
Room 4087. Samples will be stored in this location until the requisite number 
of samples are obtained for Luminex multi-plex ELISA. 
     All subjects will receive aflibercept starting on Day 1.   


 
7 
 
      
 
      
 
9. Adverse Events and Serious Adverse Events 
      The investigator will be responsible for the monitoring of the data and 
safety of study participants. The investigator will be assisted by other 
members of the study staff.       
 
      Adverse events (AEs) will be collected at each study visit by the study 
doctor from the subject. The study doctor will review all relevant information 
related to the AE to determine causality and severity, and if follow up care is 
needed.  
 
      Severe Adverse Events (SAEs) will be reported to the IRB within 24 hours 
of the study doctor being made aware or identifying the SAE. Adverse events 
will also be reported to government agencies as appropriate.       
      
    All AEs, regardless of severity will be collected following the initiation of 
study procedures and until the subject has completed the study. Each AE will 
be followed until resolution or until the AE is stable.       
 
 
 
  
 
11. Outcomes 
 
Primary 
1. Change in macular edema from baseline through Week 52 measured by 
central retinal thickness using optical coherence tomography. 
2. Change in macular volume from baseline through Week 52 measured by 
central retinal thickness using optical coherence tomography. 
3. Changes in VEGF levels in the anterior chamber from baseline through 
Week 52 measured by ELISA. 
 
Secondary 


 
8 
 
1. Change in best corrected visual acuity using Snellen Visual Acuity Charts 
from baseline through Week 52. 
2. Change in intraocular pressure from baseline through Week 52. 
3. Number of intravitreal injections from baseline through Week 52. 
4. Changes in analytes from baseline through week 52 will be studied at a 
later time. Analytes analysis will include: 
• 
CCL2/JE/MCP-1 
• 
CCL11/Eotaxin 
• 
CXCL1/GRO alpha/KC/CINC-1 
• 
CXCL2/GRO beta/MIP-s/CINC-3 
• 
EGF 
• 
FGF basic/FGF2/bFGF 
• 
IFN-alpha 2/IFNA2 
• 
IFN-beta 
• 
IFN-gamma 
• 
IL-1 alpha/IL-1F1 
• 
IL-1 beta/IL-1F2 
• 
IL-1ra/IL-1F3 
• 
IL-2 
• 
IL-3 
• 
IL-4 
• 
IL-5 
• 
IL-6 
• 
IL-7 
• 
IL-8/CXCL8 
• 
IL-10 
• 
IL-12 p70 
• 
IL-13 
• 
IL-15 
• 
IL-17/IL-17A 
• 
IL-17E/IL-25 
• 
IL-33 
• 
PD-L1/B7-H1 
• 
PDGF-AA 
• 
PDGF-AB/BB 
• 
TGF-alpha 
 
 
 
12.Analytical Plan 
 


 
9 
 
     Changes from baseline to week 52 in main study outcomes (retinal 
thickness and volume) will be evaluated using a paired t-test, supposing 
change outcomes for the n=10 study participants are normally distributed. 
Linear mixed effect models, including fixed effects for time and type of vein 
occlusion (BRVO vs. CRVO) and a random effect for study participant, will be 
employed to study longitudinal changes in primary and secondary outcomes. 
The relationship between VEGF and retinal thickness (or volume) will be 
characterized at each time point using scatterplots and Pearson (or Spearman) 
correlations.  
 
Confidentiality and Privacy      
      
      Confidentiality will be protected by collecting only information needed to 
assess study outcomes, minimizing to the fullest extent possible the 
collection of any information that could directly identify subjects, and 
maintaining all study information in a secure manner.  To help ensure subject 
privacy and confidentiality, only a unique study identifier will appear on the 
data collection form.  Any collected patient identifying information 
corresponding to the unique study identifier will be maintained on a linkage 
file, store separately from the data. The linkage file will be kept secure, with 
access limited to designated study personnel.  Following data collection 
subject identifying information will be destroyed (state the anticipated time 
the data will be destroyed, e.g. three years after closure of the study, and the 
method of destruction), consistent with data validation and study design, 
producing an anonymous analytical data set.  Data access will be limited to 
study staff.  Data and records will be kept locked and secured, with any 
computer data password protected.  No reference to any individual participant 
will appear in reports, presentations, or publications that may arise from the 
study. The data will be stored on an Excel spreadsheet in two places – Dr. 
Sappington’s office and in Dr. Nelson’s office, both protected by Wake security 
procedures.  
           
           
References      
1. Clark, W., et al. “Intravitreal Aflibercept for Macular Edema Following 
Branch Retinal Vein Occlusion”. Ophthalmology 2016;123:330-6 


 
10 
 
2. Ogura, Y., et al. “Intravitreal Aflibercept Injection for Macular Edema 
Secondary to Central Retinal Vein Occlusion: 18 Month Results of the 
Phase 3 GALILEO Study”. American Journal of Ophthalmology 2014;158: 
1032-1038.  
3. Heier, J., et al. “Intravitreal Aflibercept Injection for Macular Edema 
Secondary to Central Retinal Vein Occlusion”. Ophthalmology 2014 
121:1414-1420.  
4. Falavarjani KG, Nguyen QD. Adverse events and complications associated 
with intravitreal injection of anti-VEGF agents: a review of literature. Eye 
(Lond). 2013;27(7):787-794. doi:10.1038/eye.2013.107  
5. Eylea (Package insert). Tarrytown, NY: Regeneron Pharmaceuticals, Inc. 
08/2019.  
 
 

ICF_000.pdf: 
Official Title: Correlation of Vascular Endothelial Growth Factor Levels in Anterior 
Chamber Fluid to Disease State in Patients With Retinal Vein Occlusion Receiving 
Standard of Care Treatment  
NCT04707625
IRB-Approved Date:  6/5/23


Wake Forest School of Medicine 
INFORMED CONSENT
TITLE: CORRELATION OF VASCULAR ENDOTHELIAL GROWTH FACTOR LEVELS IN ANTERIOR CHAMBER 
FLUID TO DISEASE STATE IN PATIENTS WITH RETINAL VEIN OCCLUSION RECEIVING STANDARD OF CARE 
TREATMENT
Informed Consent Form to Participate in Research
Principle Investigator: Mark Nelson, MD, MBA
Co-Investigator: Sally Ong, MD
Co-Investigator: Rebecca Sappington, PhD
Co-Investigator: Joseph Rigdon, PhD
Site Address:             
 
       
       
   
      
       
Site Phone Number:     
Summary
You are invited to participate in a research study since you were found to have a Retinal Vein Occlusion 
(RVO).  This condition has led to vision loss. It is due to a blockage of the vein or blood vessel that takes 
blood out of the retina which is the lining in the back of the eye. This blockage has led to leakage and 
vision loss due to edema or thickening of the retina, specifically the macula which is centrally located 
and responsible for all reading vision. 
The purpose of this research is to measure different chemicals that are found in the eyes of patients 
with RVO.  Vascular Endothelial Growth Factor (VEGF) is a chemical that is over produced in your eye 
due to the RVO and leads to macular edema (swelling of the retina) and vision loss. This research project 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


will specifically measure the level of VEGF. The measurement of VEGF is done through removing a small 
amount of fluid from your eye prior to an intravitreal injection.   The removal of this fluid is being done 
as part of routine care and would normally be discarded.  Participation in this study will allow the 
researchers to keep and analyze the fluid removed from your eye and access some information from 
your medical record.
Your participation in this study is voluntary.  You do not have to participate in this study. You should talk 
to your doctor about all the choices you have. You will not lose any services, benefits, or rights you 
would normally have if you choose not to participate. 
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the study. The 
person in charge of this study is Dr. Mark Nelson (Principal Investigator, PI). If you have questions, 
suggestions, or concerns regarding this study or you want to withdraw from the study, the contact 
information is: 
Dr. Mark Nelson - Principal Investigator
If you have any questions, suggestions or concerns about your rights as a volunteer in this research, 
contact the Institutional Review Board at 
or the Research Subject Advocate at Wake 
Forest at
.
Introduction
You are invited to be in a research study. Research studies are designed to gain scientific knowledge that 
may help other people in the future. You are being asked to take part in this study because you have a 
retinal vein occlusion (RVO) .  Your participation is voluntary. Please take your time in making your 
decision as to whether or not you wish to participate. Ask your study doctor or the study staff to explain 
any words or information contained in this informed consent document that you do not understand. 
You may also discuss the study with your friends and family.
Why Is This Study Being Done?
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


The purpose of this research study is to measure the levels of Vascular Endothelial Growth Factor (VEGF) 
which is a protein over produced in the eye in patients who have RVO, and which causes the macular 
(central part of the retina responsible for reading vision) edema that is responsible for vision loss. The 
drugs that we use today to treat RVO are VEGF blocking drugs, or anti-VEGF drugs, which prevents VEGF 
from being made. We can measure the level of VEGF in the eye with a research test, ELISA, that is done 
in a laboratory and not available to the doctor treating you. By measuring VEGF, we will be able to 
predict the amount, rate, and type of drug necessary to treat you. This study mainly focuses on VEGF. 
There are other proteins that are similar to VEGF because they cause abnormal blood vessels to grow 
and leak and there are proteins that are related to inflammation or a body reaction to disease. However, 
at this time, VEGF will be the only protein studied and the samples will be frozen, saved, and evaluated 
later. 
The removal of fluid from the eye is standard of care prior to getting an intravitreal injection. The only 
thing that is investigational in this study is to take the fluid and measure it as opposed to discarding it.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
20 people at Wake Forest Baptist Health Highland Oaks will take part in this study. 
What Is Involved in the Study?
Screening period:  You will be asked to read this Informed Consent Form, or if you are unable to read 
due to low vision, it will be read to you. If you agree to participate in this study, you will sign this consent 
before any study-related activities are started.
A paracentesis will be performed after topical anesthetic or numbing is given. In a small number of 
patients, a small amount of anesthetic will be given with an injection for additional comfort, if 
requested. The paracentesis will remove a small amount of fluid from the front part of the eye. This fluid 
contains VEGF which will be the sample to determine the VEGF levels in your eye.  A paracentesis will be 
performed at every study visit prior to anti-VEGF treatment. During this procedure a syringe will be 
placed into the front part of the eye, and 0.1ml (approximately 3 drops) of fluid will be removed from 
the anterior chamber section of the eye, or the space between the iris and cornea. The fluid that is 
removed from the eye will be stored and saved for testing. After the numbing, a drop of iodine will be 
used to clean the area of the eye that will be injected including the skin around your eye. A lid speculum 
(device to keep the eye open) will be inserted under your eyelids to keep your eye open during the 
procedure. 
How Long Will I Be in the Study?
You will be in the study for 12 months. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


You can stop participating at any time. If you decide to stop participating in the study we encourage you 
to talk to the investigators or study staff first to learn about how leaving the study will not mean that 
you have to stop anti-VEGF injections. However, Dr. Nelson will tell you that vision loss will continue if 
you decide the stop all anti-VEGF injections at any time.  
WHAT ARE THE RISKS OF THE STUDY?
Being in this study involves some risk to you (as outlined below). You should discuss the risk of being in 
this study with the study staff. 
There is a slight risk of a breach of confidentiality.  We will do our best to protect your confidential 
information. The measurements of the VEGF will be stored on Wake computers and no one outside of 
Wake Forest will have access to these numbers.  The samples of fluid will be de-identified or the names 
will be replaced with numbers. Taking part in this research study may involve providing information that 
you consider confidential or private. Efforts, such as coding research records, keeping research records 
secure and allowing only authorized people to have access to research records, will be made to keep 
your information safe. We do ask permission to allow the measurements of all the study participants 
together be studied and be used in applications for research grants (funding). Again, it must be 
emphasized that individual information, for example your specific measurements, will not be shared
There also may be other risks that we cannot predict. You should tell the research staff about all the 
medications, vitamins and supplements you take and any medical conditions you have. This may help 
avoid side effects, interactions and other risks.
Are There Benefits to Taking Part in the Study?
If you agree to take part in this study, there will be no direct benefit to you. We hope the information 
learned from this study will benefit other people in the future. 
What Other Choices Are There?
You do not have to be in this study to receive treatment. You should talk to your doctor about all the 
choices you have. 
What Are the Costs?
Neither you nor your insurance company will be billed for any cost associated with the analysis of the 
VEGF. You and/or your insurance company will be billed for the cost of the intravitreal injection, the cost 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


of the anti-VEGF medications, and the cost of the eye exam and any other procedures needed to treat 
your RVO and follow their rules for deductible and copays. Costs for your regular medical care, which 
are not related to this study, will be you or your insurance company’s responsibility.
 
Will Your Research Records be Confidential?
Protected Health Information (PHI) will include patient demographics and clinical data that will be 
entered into EPIC. The anterior chamber fluid samples will be de-identified in the Highland Oaks office 
prior to sending the samples to Dr. Sappington's lab. These measurements will not be added to EPIC and 
will be kept in securely at Highland Oaks and Dr. Sappington's lab. 
The results of this research study may be presented at scientific or medical meetings or published in 
scientific journals.  Your identity and/or your personal health information will not be disclosed because 
individual data will be deindentified or given a number without your name. We are asking for permission 
to send the data to two outside organizations that are applying for a Federal Research Grant (SBIR). The 
two organizations are a company in North Carolina that is trying to make a medical device that can 
measure these study proteins quickly and the other company is a research company created years ago 
by Dr. Mark Nelson dedicated to bringing the medical science and commercial industries together.    
There is always some risk that even de-identified information might be re-identified. 
Will You Be Paid for Participating?
You will receive no payment or other compensation for taking part in this study. The findings from this 
research may result in the future development of products that are of commercial value. There are no 
plans to provide you with financial compensation or for you to share in any profits if this should occur.
Who is Sponsoring this Study?
This study is being sponsored by Wake Forest University Health Science, Department of Ophthalmology. 
The researchers do not, however, hold a financial interest with respect to this study. 
What About My Health Information?
In this research study, any new information we collect from you and/or information we get from your 
medical records or other facilities about your health is considered Protected Health Information. The 
information we will collect for this research study includes VEGF levels during the course of your anti-
VEGF treatment and this numbers will not be placed into EPIC. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


If this research study involves the diagnosis of treatment of a medical condition, then Protected Health 
Information collected from you during this study will be placed in your medical record, and will be used 
to help treat you, arrange payment for your care, or assist with Medical Center operations.
We will make every effort to keep your Protected Health Information private. We will store records of 
your Protected Health Information on a password protected computer. 
Your personal health information and information that identifies you (“your health information”) may 
be given to others during and after the study. This is for reasons such as to carry out the study, to 
determine the results of the study, to make sure the study is being done correctly, to provide required 
reports and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information are the 
research sponsor; representatives of the sponsor assisting with the research; investigators at other sites 
who are assisting with the research; central laboratories, reading centers or analysis centers; the 
Institutional Review Board; representatives of Wake Forest University Health Sciences and North 
Carolina Baptist Hospital; representatives from government agencies such as the Food and Drug 
Administration (FDA) or the Office of Human Research Protections (OHRP), the Department of Health 
and Human Services (DHHS) and similar agencies in other countries. 
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health information may 
be used to create information that does not directly identify you. This information may be used by other 
researchers. You will not be directly identified in any publication or presentation that may result from 
this study unless there are photographs or recorded media which are identifiable.
Monitors, auditors, IRB or other regulatory agencies will be granted direct access to the participant’s 
original medical record for verification of clinical trial procedures or data, without violating 
confidentiality of the participant and to the extent permitted by other applicable laws.
If required by law or court order, we might also have to share your Protected Health Information with a 
judge, law enforcement officer, government agencies, or others. If your Protected Health Information is 
shared with any of these groups, it may no longer be protected by federal or state privacy rules.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


Any Protected Health Information collected from you in this study that is maintained in the research 
records will be kept for at least six years after the study is finished. At that time any research 
information not already in your medical record will either be destroyed or it will be de-identified.
You can tell Dr. Mark Nelson that you want to take away your permission to use and share your 
Protected Health Information at any time by sending a letter to this address:
Dr. Mark Nelson – Principle Investigator
However, if you take away permission to use your Protected Health Information you will not be able to 
be in the study any longer. We will stop collecting any more information about you, but any information 
we have already collected can still be used for the purposes of the research study.
By signing this form you give us permission to use your Protected Health Information for this study.
What Are My Rights as a Research Study Participant?
Taking part in this study is voluntary. You may choose not to take part or you may leave the study at any 
time. Refusing to participate or leaving the study will not result in any penalty or loss of benefits to 
which you are entitled. If you decide to stop participating in the study we encourage you to talk to the 
investigators or study staff first to learn about any potential health or safety consequences. The 
investigators also have the right to stop your participation in the study at any time. Information that 
identifies you may be removed from the data or specimens that are collected as part of this study and 
could be used for future research or shared with others without additional consent. 
 You will be given any new information we become aware of that would affect your willingness to 
continue to participate in the study.
Whom Do I Call if I Have Questions or Problems?
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


For questions about the study or in the event of a research-related injury, contact the study investigator, 
Dr. Mark Nelson, Wake Forest Baptist Health Highland Oaks at 
.
The Institutional Review Board (IRB) is a group of people who review the research to protect your rights. 
If you have a question about your rights as a research participant, or you would like to discuss problems 
or concerns, have questions or want to offer input, or you want to obtain additional information, you 
should contact the Chairman of the IRB at 
 or the Research Subject Advocate at 
 
.
You will be given a copy of this signed consent form. 
Signatures
 I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the Privacy 
Notice, I may request one or one will be made available to me.  I have had a chance to ask questions 
about being in this study and have those questions answered.   By signing this consent and authorization 
form, I am not releasing or agreeing to release the investigator, the sponsor, the institution or its agents 
from liability for negligence.
Subject Name (Printed):_______________________________________________________
Subject Signature:____________________________________________________________
Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________________________
Person Obtaining Consent:____________________________________________________
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024


Date: _________ Time: ________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00064405
Meeting Date Approved 6/5/2023          
Version Valid Until: 6/4/2024