A Randomized, Double-Masked, Parallel Group, Multi-Center, Dose-Finding Comparison of the Safety and Efficacy of Experimental Drug Intravitreal Inserts to Sham Injection in Subjects with Diabetic Macular Edema
Study Summary
The University of Chicago and Dr. Hariprasad are conducting a study to look at the safety and effectiveness of an experimental drug delivery system. This drug delivery system is used to place the steroid-like drug into the back of the eye. Dr. Hariprasad invites you to participate in a research study if you have macular edema (swelling of the macula) due to diabetes. The macula is a small and highly sensitive part of the retina and is essential for detailed vision, such as reading. The retina is the light-sensitive tissue at the back of your eye. Macular edema in people with diabetes is caused by the leaking of one of the veins that drain blood out of the retina back to the heart.
The study drug is a compound that was shown to prevent swelling and suppress inflammation, and had been used in previous studies related to inflammation and swelling of the eye. The drug delivery system is packaged inside a small needle and is injected through the white part of your eye by your study doctor. Once the drug delivery system is injected into your eye, the drug will slowly release over a very long time (more than a year and possibly up to three years).
If you qualify and agree to participate, you will be assigned randomly by chance (similar to tossing a coin) to one of three procedures. You will receive one of the following: 0.5 μg drug dose; 0.2 μg drug dose; or a pretend procedure. After the end of 18 months, depending on your condition, the study procedure involving either the drug or a pretend procedure will be repeated as necessary.
Participants are expected to be in the study for about 36 months. There will be a total of up to 21 visits.
Participation Details
To be considered for enrollment into the study, you must:
- Be at least 18 years of age
- Give written informed consent
- Have macular edema due to diabetes
- Be willing to undergo a procedure for insertion of the experimental drug delivery system or undergo a pretend procedure which simulates an actual injection
- 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:
Sophie Gen, CCRP
sgen@bsd.uchicago.edu
(773) 702-7666
IRB: #14241A
