Clinical trial NCT00606138
Conditions: Proliferative Diabetic Retinopathy
Sponsor: Rush University Medical Center
Start date: 2008-01-01; Completion date: 2010-10-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Diabetic neovascularization refers to a type of diabetic retinopathy which is worsening by the abnormal growth of blood vessels in the back of the eye, damaging the retina. The usual treatment is a type of laser, called panretinal photocoagulation. One drawback is that the amount of space within the eye for use of this treatment eventually has its limit, and should not be used too near the part of the retina used for detailed vision (the macula). In similar eye disorders, there are certain injectable medications called anti-VEGF treatments which can slow down or stop this abnormal blood vessel growth. This study sought to compare use of ranibizumab versus standard panretinal photocoagulation in treatment of diabetic neovascularization.

Detailed description:
The purpose is to compare the efficacy of ranibizumab versus additional panretinal photocoagulation on diabetic neovascularization that is persistent despite previous treatment with panretinal photocoagulation. We hypothesize that ranibizumab intravitreal injections would induce neovascular regression in similar or better fashion than supplemental laser photocoagulation. Consented, enrolled subjects will either receive open-label intravitreal injections of 0.5-mg dose of ranibizumab or additional panretinal photocoagulation (up to 500 300-500 um laser spots) in a ratio of two-to-one (2:1) at the beginning of the study period. ETDRS best-corrected visual acuity, contrast sensitivity, and Optos color photography will be performed at enrollment, at weeks 1, 2, 3 and 4, and at months 2, 3, 4, 5 and 6. The subjects will undergo fluorescein angiography utilizing the Optomap FA (fluorescein angiography) system and optical coherence tomography (OCT) at enrollment, at weeks 2 and 4, and at months 2, 3, 4 and 6. The subjects will be followed for a 6-month period for stabilization, regression, or recurrence of neovascularization. In addition, patients will be evaluated for occurrence of macular edema.

Arms: arm 1: Intravitreal injection of 0.5-mg dose of ranibizumab arm 2: Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
Interventions: intervention 1: ranibizumab intervention 2: Laser photocoagulation
Intervention descriptions: intervention 1: One 0.5 mg intravitreal injection intervention 2: panretinal photocoagulation (up to 500 300-500 um laser spots)

Protocol documents:
ICF_001.pdf: 
U.S. ICF:  Ranibizumab (Lucentis) 
Page 1 of 20
Subject’s initials _______
Protocol Number FVF3817s
Version Date July 23, 2008
RUSH UNIVERSITY MEDICAL CENTERSubject 
Information Sheet and Consent Form
Principal Investigator: Mathew W. MacCumber, M.D.,
Ph.D.
Sub-Investigators: 
Jack A. Cohen, M.D., Michael J. 
Davis, M.D., Pauline T.
Merrill, M.D., and Kirk H. Packo, 
M.D.
Site Address: 
Rush University Medical Center
Department of Ophthalmology
1725 W. Harrison St. 
Chicago, Illinois 60612
Phone:
312-942-2117
Study Title:   
Investigation of Ranibizumab for 
the Treatment of Persistent 
Diabetic Neovascularization as 
Assessed by Super Wide-Field 
Angiography (Optos)
Sponsor:
Genentech, Inc.
____________________________________________
INTRODUCTION
You are being invited to participate in a research study 
at Rush University Medical Center. This consent form 
provides you with information about the study so you 
can understand the possible risks and benefits of 
participating.  The investigator and/or sub-investigators 
will answer any questions you may have about this 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
study.  Before deciding whether to participate, you 


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Subject’s initials _______
Protocol Number FVF3817s
Version Date July 23, 2008
should read this form carefully and ask any questions 
you have regarding the information it contains.  Once 
the study has been explained and you have had all of 
your questions answered to your satisfaction, you will be 
asked to sign this consent form if you wish to 
participate. 
You are being invited to participate in this study 
because you have proliferative diabetic retinopathy that 
has previously been treated with panretinal 
photocoagulation, also called laser treatment.  You still 
have active disease even though you have been 
treated.
Proliferative diabetic retinopathy occurs when there is 
not enough oxygen to the retina.  Because of this, the 
retina produces substances that cause new blood 
vessels to grow.  These blood vessels are not able to 
provide oxygen to the retina.  They are fragile and can 
break and lead to scar formation.  These blood vessels 
can then lead to vitreous hemorrhage (bleeding in the 
eye), retinal detachment (separation of the retina from 
the back surface of the eye), glaucoma (increased 
pressure in the eye), loss of vision and loss of the eye.
PURPOSE OF THE STUDY
The purpose of this research study is to test a new drug 
for the treatment of proliferative diabetic retinopathy.  
This drug is approved by the U.S. Food and Drug 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
Administration for treatment of wet (neovascular) 


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macular degeneration, but is not approved for the use in 
proliferative diabetic retinopathy. The drug is called 
ranibizumab.  This drug is given by injection into the 
eye.  
The drug being tested blocks a growth factor (a protein 
in the body which provides nutrition to other cells) that is 
thought to be involved in formation of abnormal blood 
vessels that are formed in proliferative diabetic 
retinopathy. 
Your voluntary participation in this study may help 
determine if ranibizumab will stop the growth of the 
abnormal blood vessels and to see if it is safe and well 
tolerated. 
There are two groups in the study; if you enroll in the 
study, you will be assigned to participate in only one 
group.  
The first group (Group A) will enroll seven (7) subjects.  
Subjects enrolled in this part of the study will initially 
receive one dose of ranibizumab in a dose of 0.5 
milligrams (mg) by injection into the eye.  The second 
group (Group B) will have three (3) subjects.  These 
subjects will receive additional laser (panretinal 
photocoagulation) up to 500 additional spots in one 
treatment session.  Subjects will be entered into the 
study groups based on when they enroll in the study.  
The first two subjects (Subject A and Subject B) will be 
entered into Group A and receive ranibizumab, the third 
subject (Subject C) will be entered into Group B and 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
receive panretinal photocoagulation and so forth.


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Subject’s initials _______
Protocol Number FVF3817s
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A total of ten (10) subjects at one study center will take 
part in this study.
RESPONSIBILITIES/EXPECTATIONS AND 
PROCEDURES
The duration of the study is 6 months.
SCREENING
If you volunteer to participate in this study, you will be 
screened within 30 days before study entry to check if 
you are a suitable candidate for this study.  The 
screening tests include the following:
Eye Exam
oThe eye exam will include measurement of your 
visual acuity (the ability to read letters on the 
vision chart).  You will also have a contrast 
sensitivity test, which tests how well you see 
different shades of gray. The doctor will also look 
at your pupils and eye movements. The 
structures inside the eye will be examined 
through a special microscope.  The lens and 
back of your eye will also be examined after 
drops have been placed in your eyes to dilate 
(enlarge) your pupil.  The pressure in your eye 
will be measured.  The doctor will also study your 
retina with an ophthalmoscope (an instrument 
with a strong light and magnifying lens).

ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
A review of your medical history 


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A review of any medications you are or have been 
taking
Urine pregnancy test, if applicable
oIf you are a female of childbearing potential, you 
will need to take a urine pregnancy test.  This test 
must have a negative result in order for you to be 
in the study. You must use an effective method of 
birth control for the duration of the study.
If you are eligible for study entry, you will be randomly 
assigned to one of the two groups in the study.  Once 
enrolled you will have: 
oA blood test that will measure your hemoglobin A1c 
(HbA1c). This is a test that determines your blood 
sugar level over the last three months. 
Approximately 3 teaspoons (15 mL) will be drawn 
during this visit.
oYou will also have a physical examination and vital 
signs (heart rate, breathing rate, blood pressure, 
temperature) taken.
TREATMENT PHASE
You will either be assigned to receive 0.5 milligrams 
(mg) of ranibizumab or additional panretinal 
photocoagulation (PRP).  You will receive one injection 
of ranibizumab or one session of PRP consisting of up 
to 500 additional laser spots (Day 0). 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
Initial Treatment Day (Day 0)


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When you first arrive, your visual acuity (the ability to 
read letters on the vision chart) will be measured and 
you will have contrast sensitivity vision testing.  You will 
then receive eye drops to dilate (enlarge) your pupil. 
Similar to the eye exam you had when you were 
screened for the study, the doctor will look at your eyes. 
The pressure of your eyes will also be obtained. 
You will have a fluorescein angiogram test at this visit 
using a machine called the Optomap fa.  This is a 
picture test where dye is injected into a blood vessel in 
your arm through a needle.  The needle is temporary 
and is removed after the dye is injected.  This test will 
look at the blood vessels in your eyes.  You will also 
have fundus photographs (pictures of the interior 
surface of the eye) at this visit, which will be with the 
same machine as the fluorescein angiogram.  At this 
visit, you will also have Optical Coherence Tomography 
(referred to as OCT).  This test uses a dim beam of light 
to measure the thickness of the retina. You will look into 
a machine at a pattern of flashing and rotating red and 
green lights, first with one eye and then the other.
Once all of these tests are complete, you will be able to 
receive the injection of ranibizumab or laser treatment.
To prepare for the injection, anesthetic (numbing) drops 
and antibiotic drops will be placed on the surface of the 
eye.  An antiseptic solution will be used to reduce the 
chance of infection.  The eye doctor may decide that 
you should also have an anesthetic injection under the 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
surface of the eyeball.  After the preparation is 


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Version Date July 23, 2008
complete, the ranibizumab will be injected into your 
study eye.  Dr. MacCumber, Dr. Davis, Dr. Cohen, Dr. 
Merrill or Dr. Packo, using a fine needle and syringe, will 
perform all injections.  
After the injection, you will remain in the eye clinic for 
about an hour.  Tests will be performed on your eye to 
determine how well you count fingers, detect hand 
motion and see light, as well as how much pressure is 
within your eye.  You will be given antibiotic eye drops 
to self-administer four times a day for three days post-
injection.
Before beginning the laser treatment, anesthetic drops 
will be placed on the surface of the eye.  The eye doctor 
may decide that you should also have an anesthetic 
injection behind the eye.  A special contact lens is then 
placed on the eye during the treatment.  You will sit with 
your chin and forehead resting against a frame during 
the treatment.  The treatment usually takes anywhere 
from 10 to 30 minutes.  We will ask you to keep your 
head and eye still during the actual treatment, but you 
will be able to take “breaks” to rest, if you need them.  
You will see bright flashes of light.  You may experience 
slight discomfort, but there is usually no pain.
Two days after you are treated, you will receive a 
telephone safety check from the study coordinator. You 
will be asked to return 1 week after your initial 
treatment, and again 2, 3 and 4 weeks and 2, 3, 4 and 6 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
months after the treatment.  You will have a full eye 


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exam at all visits, including having drops put in your 
eyes to test the eye pressure and to dilate (make the 
pupil large) the eyes.
This is a summary of what will happen at each visit:
1 week, 3 weeks, and 5 month visit:
Vital signs
Intraocular pressure (eye pressure)
Full eye exam, including dilation
Visual acuity
Contrast sensitivity vision testing
Color photographs of eyes
2 and 4 weeks, 2, 3, 4 and 6 month visit:
Vital signs
Intraocular pressure (eye pressure)
Full eye exam, including dilation
Visual acuity
Contrast sensitivity vision testing
Fluorescein angiography with Optomap FA
Optical Coherence Tomography (OCT)
Color photographs of eyes
Genentech will provide ranibizumab for the study and 
pay for any tests that are done.
Should your disease change during the course of the 
study, you will be notified by your doctor of other options 
that may be available to you, which may include 
panretinal photocoagulation.  Treatment in the non-
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
study eye for diabetic retinopathy is allowed during the 


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course of this study.  Your doctor and you will decide on 
the best treatment options.
If you have any health-related problems, you should 
contact the study nurse or your doctor as soon as 
possible.
POTENTIAL RISKS AND DISCOMFORTS
During your participation in this study, you are at risk for 
the side effects described below.  You should discuss 
these with the study doctor.  There may also be other 
side effects that we cannot predict.  Other medicines 
may be given to lessen the side effects and discomfort.  
Many side effects go away shortly after you discontinue 
therapy, but in some cases, side effects can be serious, 
long lasting, or permanent.
STUDY DRUG ADMINISTRATION
Ranibizumab has been studied in humans in previously 
completed clinical trials.  The following side effects have 
been observed:
Temporary redness of the injected eye
Minor and self-resolving bleeding related to the 
injection procedure
Dull pain in the injected eye
Mild and temporary burning and stinging
Vision disturbances, including decrease in vision

ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
Self-resolving bleeding inside the injected eye


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Infection inside and/or outside the treated eye 
(endophthalmitis)
Mild and self-resolving inflammation on the inside of 
the eye
Severe inflammation in the inside of the eye (uveitis)
Blockage of the blood flow in the main vein inside the 
eye (central retinal vein occlusion)
Temporary increase in the pressure inside the eye 
(intraocular pressure)
Damage to the lens inside the eye
A tear through the retinal tissue in the eye (retinal 
tear)
A rip in the pigment cell layer that lies beneath and 
nourishes the retina (retinal pigment epithelial [RPE] 
tear)
Inadequate response of the pupil to light entering the 
eye (afferent pupillary defect/Marcus-Gunn Pupil)
Some of the complications listed above may result in 
permanent loss of vision or loss of the eye.
If you have a history of glaucoma, you may be at more 
risk for experiencing increased pressure within your eye 
after an injection of any substance, including 
ranibizumab.  To participate in this study, it must be 
shown that your glaucoma is well controlled with 
medication and that you take your medication as it has 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
been prescribed by your doctor.


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Tests have shown that low levels of ranibizumab can 
reach your blood after injection into the eye.  The 
significance of this is not well understood.  Therefore, 
the risk of having a side effect involving a body system 
other than the eye is unknown.  However, you will be 
carefully monitored for signs of side effects.  Examples 
of possible side effects involving the body as a whole 
may include slowed wound healing or a tendency for 
more frequent or prolonged bleeding, heart attack and 
stroke.
In recent clinical trials, side effects occurring in less than 
5% of subjects who received ranibizumab included heart 
attack (both fatal and non-fatal) and stroke.
There is a chance that your vision may worsen.  
Worsened vision could be due to progression of your 
diabetes, to a side effect of ranibizumab injection, or for 
other reasons.
There is a chance that you will experience an allergic 
reaction to ranibizumab.  Allergic reactions may be mild, 
such as skin rash or hives, to severe, such as breathing 
difficulties or shock.  A severe allergic reaction would 
require immediate medical treatment and could result in 
permanent disability or death.  An allergic reaction can 
also cause dry or itchy eye.  It is not possible to predict 
in advance if any of these problems will develop, but if 
they do, you will be promptly treated. 
As is true for any experimental drug, unknown and 
potentially serious or life-threatening side effects could 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
occur with ranibizumab.  


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INJECTION INTO THE EYE
Injecting any medication into the eye may result in 
increased pressure within the eye, inflammation, 
cataract formation, a feeling of a foreign body in the eye, 
bleeding within the eye, damage to the retina (such as a 
retinal detachment or tear), or damage to other eye 
structures.
It is possible that you may get an infection within your 
eye (endophthalmitis) as a result of injection into the 
eye.  An infection in the eye may lead to vision loss or, 
in rare cases, loss of the eye.  Antiseptic cleaning of the 
eye and administration of topical antibiotics are given to 
minimize the risk of infection.
There may be minor discomfort from injection of 
ranibizumab.  The injections will be performed by a 
specialist and will be done using a small needle after 
receiving local numbing (anesthesia).  Your doctor will 
treat your symptoms according to his or her judgment. 
Injection of the numbing medication may lead to minor 
bleeding under the surface of your eyeball; the bleeding 
will usually stop on its own, and the surface of your eye 
should return to its usual appearance.
BLEEDING ASSOCIATED WITH THE USE OF 
ANTICOAGULANT MEDICATION
The use of certain kinds of anticoagulant 
(blood-thinning) medications (for example, aspirin) is 
permitted during this study.  However, these types of 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
medication are known to increase the chance of 


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bleeding in the event of a wound or tissue injury and 
could possibly increase the chance of internal eye 
bleeding if you have eye inflammation because of 
receiving the study drug. The only prohibited 
anticoagulant is Coumadin.
PANRETINAL PHOTOCOAGULATION
Complications from photocoagulation are very 
uncommon but they do occur.  It is possible that you will 
be worse after photocoagulation than you are right now.  
Damage to the cornea, iris and retina have in rare 
instances been known to occur from photocoagulation.  
The results of this damage could be a worsening of 
vision, blindness and disease of the eye requiring 
prolonged treatment.  It is possible that 
photocoagulation will make whatever disease is present 
in the eye develop more rapidly than it would without 
photocoagulation.  It is also possible that whatever is 
present in the eye before photocoagulation will come 
back after the procedure is performed.
BLOOD DRAW
For the HbA1c blood test, insertion of the needle into 
your skin may cause some pain, discomfort, and slight 
bruising.  You also may faint or feel faint.  You may 
develop an infection at the site where the needle goes 
in.  Fainting, feeling faint, or developing an infection are 
not likely to happen.  Less than 3 teaspoons (15 mL) of 
blood will be taken during a single visit for HbA1c 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
testing.


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PREGNANCY RISKS
The effects of ranibizumab on a fetus are unknown and 
may be harmful; therefore, you should not become 
pregnant or father a child while in this study.  To 
participate in this study, females who are capable of 
bearing children must agree to use an effective method 
of birth control (i.e., birth control pills, patches,  
intrauterine device (IUD), barrier method such as 
condoms or diaphragm with spermicide, hormone 
implants or surgical sterility) to prevent pregnancy and 
will be required to take a pregnancy test before entry 
into this study (during the screening phase).  If you are 
pregnant, you cannot be in this study because of 
possible harm to the fetus.  If at any time during the 
study you suspect that you have become pregnant, 
please notify the study doctor immediately.  If after your 
participation in the study is over, you suspect that you 
have become pregnant within 90 days of the last 
administration of study drug, you should notify your 
doctor immediately. You can discontinue birth control 
ninety days after you complete your participation in the 
study.  If you are a male and your partner becomes 
pregnant during the study, you should also notify the 
study doctor immediately.
You should not nurse (breast feed) a baby while in this 
study because ranibizumab may enter breast milk and 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
possibly harm your child.


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Males must also use birth control (i.e., condoms) while 
participating in this study.
POSSIBLE BENEFITS
The study treatment may help preserve and/or improve 
your vision because it may help stop the growth of 
abnormal blood vessels responsible for your loss in 
vision.  However, there is no guarantee that the 
treatment will be successful.  No direct benefit can be 
promised to you as a result of your participation in this 
research study.  Your participation in this study may 
lead to new treatments for persons who have 
proliferative diabetic retinopathy.
ALTERNATIVES TO PARTICIPATION
If you decide not to participate in this study, your 
proliferative diabetic retinopathy will be treated in the 
routine manner.  Your doctor will discuss your options 
with you.  Your choice not to participate in this study will 
not affect your medical care in any way.
NEW FINDINGS
Any significant new findings regarding ranibizumab that 
become known during the course of the research study 
that might reasonably affect your willingness to 
participate will be provided to you.  You should discuss 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
further options with the study doctors at that time.


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COST AND COMPENSATION
Genentech will pay for all study-related procedures/tests 
except for the cost of the eye exam at Visit One 
(baseline), 4 weeks, 3 months, and 6 months (end of 
study visit) as well as the cost of the OCT test at 4 
weeks, 3 months and 6 months.  You and/or your 
insurance company are responsible for the above 
mentioned exams/tests. Genentech will supply 
ranibizumab for Group A of the study.  If you are 
assigned to Group B, you and/or your insurance 
company will be responsible for the costs associated 
with the panretinal photocoagulation.
Dr. Mathew MacCumber is being paid by the sponsor of 
the study, Genentech, to conduct this research study.  
This payment will be used to pay for the costs of the 
study which may include such things as tests, 
medications, etc.  Also, a portion of the money will be 
given to Rush University Medical Center.  One example 
of what this payment will cover would be the cost of rent 
for office space within the medical center.
VOLUNTARY PARTICIPATION
Participation in this research study is voluntary.  There 
is no penalty if you decide not to take part in this study.  
You will not be penalized if you decide to stop 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
participating in this research study.


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RESEARCH RELATED INJURIES
If you are injured or become ill from the study drug 
being studied or the required study procedures, medical 
treatment is available.  You and/or your insurance 
company will be responsible for the cost for any physical 
injury that specifically results from the study drug.  
Rush University Medical Center does not have a 
program for financial compensation or other forms of 
compensation for injuries which you may incur as a 
result of participation in this study. No payments or 
compensation will be provided for lost income. 
TERMINATION/WITHDRAWAL
Your participation in this clinical study may be ended at 
any time for medical reasons or because Genentech 
finds it necessary to limit or terminate this clinical trial.
The doctor may decide to hold or stop the ranibizumab 
injections at any time during the study for safety 
reasons.
You may choose to withdraw from the study at any time 
without consequence to the medical care you will 
receive.  You will continue to receive the medical care to 
which you were previously entitled before your 
participation in the study.  
If during the course of the study you decide to withdraw 
from the study, or if your doctor or the Sponsor decides 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
to withdraw you from the study, you will be asked to 


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complete a scheduled termination visit for safety 
reasons.  During this visit you will complete the same 
examinations as the final clinic visit scheduled at the 
end of the 6-month period.  As a subject in this 
research, your responsibilities include returning for 
scheduled study visits and informing your doctor of any 
health problems during the study.  Should you miss 
more than two scheduled doses of study treatment in a 
year because of a side effect or other reason, serious 
consideration will be given by your doctor and 
Genentech to discontinue you from the study.  
If you experience a side effect considered by your 
doctor to be possibly related to study drug, you will be 
asked to visit the clinic periodically, even after the study 
has ended, and until the event resolves or until your 
doctor assesses it as chronic or stable.
CONFIDENTIALITY
Records of participation in this research study will be 
maintained and kept confidential as required by law. 
The data from this study will be used by the study 
sponsor, Genentech, Inc., and its designees to submit to 
the Food and Drug Administration (FDA) and other 
regulatory agencies so that they may assess the safety 
and effectiveness of the study drug.  Strict confidentiality 
concerning your medical records will be maintained by 
your doctor, the study sponsor and its designees.  Your 
personal records will not be released or revealed 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
beyond the scope of the study without your permission.  


U.S. ICF:  Ranibizumab (Lucentis) 
Page 19 of 20
Subject’s initials _______
Protocol Number FVF3817s
Version Date July 23, 2008
If information from this study is presented publicly or 
published in a medical journal, you will not be identified 
by name, picture, or any other personally identifying 
information. Identification numbers instead of names will 
be used to identify study data.
The Rush Institutional Review Board (IRB) will have 
access to your files as they pertain to this research 
study.  The IRB is a special committee that reviews 
human research to check that the rules and regulations 
are followed.  Your identity will not be revealed on any 
report, publication, or at scientific meetings.
QUESTIONS
Questions are encouraged.  If there are any questions 
about this research study or if you suffer a research 
related injury, please contact Dr. Mathew MacCumber at 
312-942-2117.  Questions about the rights of research 
subjects may be addressed to the Rush Research and 
Clinical Trials Administration Office at 312-942-5498.
By signing below, you are consenting to participate in 
this research study.  You have read the information 
given. You have had the opportunity to ask questions, 
which have been answered satisfactorily to you by the 
study personnel.  You do not waive any of your legal 
rights by signing this consent document.  You will be 
given a copy of the signed and dated consent form for 
your records. You are also aware that the investigator at 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
my hospital will also retain a copy in his or her files. 


U.S. ICF:  Ranibizumab (Lucentis) 
Page 20 of 20
Subject’s initials _______
Protocol Number FVF3817s
Version Date July 23, 2008
You hereby give your consent to participate in this 
clinical trial.  You also hereby authorize Rush to use and 
disclose your Authorized Health Information in the 
manner described in this Consent Form. 
____________________________________
Subject Name  (print)
____________________________________
_______________
Subject Signature
Date
____________________________________
Name of person conducting informed consent 
discussion (print)
____________________________________
_______________
Signature of person conducting informed 
consent discussion
Date
I observed the signing of this document.
____________________________________
Witness Name (print) 
____________________________________
_______________
Witness Signature 
ORA: L06120402-CR02   Date IRB Approved: 8/2/2010   Expiration Date: 11/2/2010
Date

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