Status:
TERMINATED
The Effect of Macugen in Patients With Chronic, Post-Operative Cystoid Macular Edema
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Eyetech Pharmaceuticals
Conditions:
Cystoid Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 o...
Detailed Description
While only 1% to 2% of people following cataract surgery develop visual acuity loss from chronic post-surgical cystoid macular edema (CME), this represents approximately 20,000 individuals in the U.S....
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00358423
Start Date
July 1 2006
End Date
February 1 2007
Last Update
May 12 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287