An Exploratory Study of the Safety, Tolerability, and Biological Effect of Intravitreal Administration of Experimental Drug in Patients with Neovascular Age-Related Macular Degeneration

Study Summary

The University of Chicago and Dr. Hariprasad are conducting a study to look at the safety of an experimental drug for subjects with "wet" or neovascular Age-Related Macular Degeneration (AMD).

Dr. Hariprasad invites you to participate in a research study if you have been diagnosed by your doctor as having an eye condition known as choroidal neovascularization (CNV) as a result of having a condition known as "wet" or advanced age-related macular degeneration (AMD). AMD is a common disease in people older than age 55, and in some patients it causes a gradual loss of vision. CNV is the growth of new, abnormal blood vessels under the retina. These vessels may leak fluid, bleed or lift up the retina causing the gradual loss in vision. The growth of abnormal, diseased blood vessels in the back of the eye is, in part, caused by excessive amounts of a substance called Vascular Endothelial Growth Factor (VEGF), which is made by cells in the retina. The experimental drug is designed to trap VEGF and is being studied to determine whether it blocks the formation and growth of new blood vessels in the eye.

Participation Details

There will be 13 planned visits in the study. Visits one through nine are considered the "Active Phase" of the study while visits 10 through 13 are considered the "Extended Follow-Up Phase".

There are two parts in this trial, A and B. Part A of the trial will look at the safety of the experimental drug and part B will study the safety and effectiveness of the study drug as compared to Macugen® (an FDA-approved drug for AMD, which is a registered trademark of EyeTech Pharmaceuticals). Subjects may participate in either Part A or Part B, but not in both.

• In part A, if Dr. Hariprasad determines that you are eligible for the study and agree you to participate, you will be assigned to one of three study drug doses. You will receive one injection of study medication at your second visit.
• Part B is planned to start after Part A is finished. In part B, subjects will be randomly assigned by chance (like flipping a coin) to receive study drug or Macugen®. You will have a 50 percent chance of receiving VEGF Trap and a 50 percent chance of receiving Macugen®. If you are assigned to VEGF Trap, you will receive one dose of VEGF Trap plus one sham injection (your eye will be prepared as if you are going to receive an injection, but no injection will be given). If you are assigned to Macugen®, you will receive two doses of Macugen®. The dose level of VEGF Trap will be determined from safety information obtained from Part A of the study. The dose of Macugen® will be the prescribed dose recommended by the manufacturer.

Participants are expected to be in the study for about 15 months and have 13 scheduled study visits during each part of the trial.

• You may receive no benefit from participating in this study. It is possible that the experimental drug may prevent the growth of abnormal blood vessels below your retina and help slow down vision loss in the treated eye. If you participate in Part B and are assigned to receive Macugen®, this medication will be provided at no cost to you. You will also have the knowledge that the results from this study may contribute to better treatment methods for patients with AMD like yourself.
• This is the first time the VEGF Trap will be given to humans with AMD by direct injection into the eye. VEGF Trap administration and the procedures in this study have risks and discomforts associated with them. There may be side effects associated with the intraocular injection of VEGF Trap or Macugen® that are unknown at this time. You will be made aware of any significant new findings that may affect your decision to remain in the study. More information regarding risks will be provided in the patient informed consent form.

To be considered for enrollment into the study, you must:

• Be at least 50 years old
• Give written informed consent
• Have choroidal neovascularization (CNV) as a result of having a condition known as "wet" or advanced age-related macular degeneration (AMD)
• Be available for study visits for the duration of the study
• Not be pregnant or breastfeeding during the study
• Meet study eligibility criteria as evaluated by Dr. Hariprasad
• Understand the study instructions and be able to follow the study instructions

Study Director: Seenu Hariprasad, MD
Department: Ophthalmology

For more information contact:
Kimberly Allison
(773) 702-7666
IRB: #13911A