Macugen to Prevent Worsening of Macular Edema Following Cataract Surgery in Diabetics

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This research is being conducted to look at the effects of an intraocular drug (pegaptanib, also called Macugen) for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) that often occurs following cataract surgery in patients with diabetic eye disease. Swelling in the retina can lead to blurry vision, and Macugen may reduce this swelling. Eyedrops that decrease inflammation also may help to stop some of the swelling. We are testing this drug (pegaptanib) to see if it can decrease swelling in the retina and improve vision in patients with diabetes who are having 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) with diabetes mellitus

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

• Best corrected visual acuity better than or equal to 20/800 in the fellow eye

• DME in the study eye (eye scheduled to undergo cataract surgery) as documented on OCT as a center point thickness of at least 250 microns no more than 3 weeks prior to cataract surgery

• No prior laser photocoagulation in the study eye for at least 4 months prior to cataract surgery

• 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.

Exclusion Criteria:

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

• Macular edema due to non-diabetic etiologies such as vein occlusion

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

• Media opacity will not be an exclusion criterion provided that the investigator can assess the presence or absence of DME on OCT