The Effect of Macugen in Patients With Chronic, Post-Operative Cystoid Macular Edema

• Status: Terminated
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This research is being done to look at the effects of an experimental drug called pegaptanib (also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that can occur after cataract surgery. Swelling in the retina can lead to blurry vision.

The only treatment available for this condition is eye drops that decrease swelling in the back of the eye, but eye drops may not decrease the swelling in everyone. We want to see if pegaptanib can decrease swelling in the retina and improve vision in patients with swelling after cataract surgery.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Eyetech Pharmaceuticals

Criteria

Inclusion Criteria:

• Adults (ages 18 years or older)

• Best corrected visual acuity < 20/40 but no worse than 20/800 in the study eye

• Best corrected visual acuity better than or equal to 20/200 in the fellow eye

• Post-surgical CME in the study eye as documented on OCT (central subfield >/= 250 microns)

• Women of child-bearing potential who are interested in participating in this study will use two effective forms of contraception prior to initiation of pegaptanib and then throughout the remainder of the study. For women of childbearing potential, results from a urine pregnancy test will be obtained prior to each injection with pegaptanib. Urine samples will be disposed of after the test is performed.

• Initiation of pegaptanib or sham injections may begin following at least 12 weeks of topical therapy for CME after cataract surgery or the other eye,if the best-corrected visual acuity has not improved by at least 5 letters and if the center point thickening on OCT has not improved by at least 20%. Patients who have been on topical ketorolac for greater than 12 weeks are still eligible for this study.

Exclusion Criteria:

• History of intravitreal steroid (triamcinolone) injection into the study eye or fellow eye within 4 months prior to cataract surgery

• CME due to other etiologies such as vein occlusion and diabetes.

• Retinal diseases that preclude evaluation of the macula for edema (e.g., macular hole).