Phase 3 Trial of Experimental Dexamethasone Drug Delivery System in the Treatment of Patients with Diabetic Macular Edema

Study Summary

The University of Chicago and Seenu Hariprasad, MD 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.

Dexamethasone is a steroid-like drug that was shown to prevent swelling and suppress inflammation, and had been used in previous studies related to macular edema. In past studies dexamethasone was used as a single injection into the eye. However, necessary concentrations of dexamethasone within the eye could not remain long enough to lead to effective results. Thus, the researchers hope that the experimental system will deliver dexamethasone in slow sustained doses so that necessary concentration of the drug is achieved.

You may receive no benefit from participating in this study. However, knowledge gained from this study may help in the future treatment of people with macular edema.

If you qualify and agree to participate, you will be assigned randomly by chance (similar to tossing a coin) to one of 3 procedures. You will receive one of the following: 700 μg drug dose; 350 μg drug dose; or a pretend procedure. After the end of 6 months, depending on your condition, the study procedure involving either the drug or a pretend procedure will be repeated as necessary UNLESS your vision has improved to normal AND the macular edema is gone or nearly gone.

Participants are expected to be in the study for about 36 months. There will be a total of up to 36 visits. Subjects will be paid up to $1,461 for participation on this study.

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: #13835B