Study of an Experimental Drug Delivery System in the treatment of Non-Infectious Ocular Inflammation of the Anterior Segment in Subjects with Anterior Uveitis

Sponsored by Allergan , Inc.

Study Summary

Dr. Howard Tessler of The University of Illinois at Chicago is conducting a study to determine 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. You may be able to participate in this research study if you have persistent anterior uveitis.

Dexamethasone is a U.S. Food and Drug Administration (FDA) and Health Canada approved steroid available in eye drops for treating various eye conditions. This experimental drug delivery system s lowly releases dexamethasone into the back of the eye and dissolves over time. Researchers hope that this drug delivery system will achieve therapeutic levels at the sites of inflammation, while potentially minimizing steroid exposure to non-target areas of the eye.

If you participate in this study, you may receive no direct benefit. However, the possible benefits for other people with this condition may include more information about anterior uveitis and the development of future treatments.

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 sham procedure (the sham procedure does not contain any study medication).

There will be up to 15 scheduled study visits over a period of approximately 26 weeks. Your participation in this study will last for approximately 6 months. Subjects will be paid $40 per visit for participation in this study.

Participation Criteria

To be considered for enrollment in this study, you must:

• Be at least 18 years of age

• Give written informed consent

• Have persistent non-infectious anterior uveitis in at least one eye

• Be willing to undergo a procedure for insertion of the experimental drug delivery system or undergo a sham procedure which mimics an actual injection

• Be available for study visits for the duration of the study

• Not be pregnant, breastfeeding, or planning a pregnancy at any time during the study

• Be able to understand and follow the study instructions

• Not have participated in an investigational drug or device study within the 30 days prior to study enrollment

• Meet all study eligibility criteria as evaluated by Dr. Tessler

Principal Investigator: Howard Tessler , MD

Department: Ophthalmology