Clinical trial NCT04707625: Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Retinal Vein Occlusion
Keywords: Vision Loss
Eye Injections
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive the same standard of care treatment.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* Willingness and ability to provide written informed consent.
* Diagnosis of Retinal Vein Occlusion with macular edema and central foveal thickness of greater than or equal to 300 microns confirmed by intravenous fluorescein angiography and Optical Coherence Tomography
* Visual Acuity between 20/25 and 5/200

Exclusion Criteria:

* Bilateral Retinal Vein Occlusion
* Vision worse than 5/200 in study eye
* History of myocardial infarction, ischemia, or cerebrovascular accident within 6 weeks of screening
* Concurrent Proliferative Diabetic Retinopathy and/or Maculopathy
* Concurrent Exudative Age-related Macular Degeneration
* Concurrent optic neuropathy with the presence of an afferent pupillary defect
* Previous vitrectomy in the study eye
* Currently pregnant or planning to become pregnant during the duration of the study. Women currently breastfeeding are also excluded.
* Previous treatment for retinal vein occlusion in the study eye
* Any current medical condition which, in the opinion of the investigator is considered to be uncontrolled
* History of allergy or hypersensitivity to study treatment, fluorescein, or any study procedure and treatment related ingredients (e.g. topical anesthetics, betadine, etc.)

Primary outcomes:
measure: Change in Macular Edema
timeFrame: Baseline through week 35
measure: Change in Macular Volume
timeFrame: Baseline through week 35
measure: Change in Vascular Endothelial Growth Factor (VEGF) Level in Anterior Chamber
timeFrame: Baseline through week 35
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline through week 35
measure: Change in Intraocular Pressure (IOP)
timeFrame: Baseline through week 52
measure: Number of Intravitreal Injections
timeFrame: Baseline through week 52
measure: Change in Analytes - Chemokine (C-C Motif) Ligand (CCL)s
timeFrame: Baseline through week 52
measure: Change in Analytes - Chemokine (C-X-C Motif) Ligand (CXCL)s
timeFrame: Baseline through week 52
measure: Change in Analytes - Growth Factors
timeFrame: Baseline through week 52
measure: Change in Analytes - Interferons
timeFrame: Baseline through week 52
measure: Change in Analytes - Proteins
timeFrame: Baseline through week 52
measure: Change in Analytes - Interleukins
timeFrame: Baseline through week 52
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mark Nelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark WL, Boyer DS, Heier JS, Brown DM, Haller JA, Vitti R, Kazmi H, Berliner AJ, Erickson K, Chu KW, Soo Y, Cheng Y, Campochiaro PA. Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion: 52-Week Results of the VIBRANT Study. Ophthalmology. 2016 Feb;123(2):330-336. doi: 10.1016/j.ophtha.2015.09.035. Epub 2015 Oct 30.
citation: Ogura Y, Roider J, Korobelnik JF, Holz FG, Simader C, Schmidt-Erfurth U, Vitti R, Berliner AJ, Hiemeyer F, Stemper B, Zeitz O, Sandbrink R; GALILEO Study Group. Intravitreal aflibercept for macular edema secondary to central retinal vein occlusion: 18-month results of the phase 3 GALILEO study. Am J Ophthalmol. 2014 Nov;158(5):1032-8. doi: 10.1016/j.ajo.2014.07.027. Epub 2014 Jul 25.
citation: Heier JS, Clark WL, Boyer DS, Brown DM, Vitti R, Berliner AJ, Kazmi H, Ma Y, Stemper B, Zeitz O, Sandbrink R, Haller JA. Intravitreal aflibercept injection for macular edema due to central retinal vein occlusion: two-year results from the COPERNICUS study. Ophthalmology. 2014 Jul;121(7):1414-1420.e1. doi: 10.1016/j.ophtha.2014.01.027. Epub 2014 Mar 27.
citation: Falavarjani KG, Nguyen QD. Adverse events and complications associated with intravitreal injection of anti-VEGF agents: a review of literature. Eye (Lond). 2013 Jul;27(7):787-94. doi: 10.1038/eye.2013.107. Epub 2013 May 31.