Status:
TERMINATED
Macugen to Prevent Worsening of Macular Edema Following Cataract Surgery in Diabetics
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 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 ...
Detailed Description
Macular edema occurs as a complication of cataract surgery in approximately 2% of all surgeries. In this condition, cystic, fluid-filled spaces develop in the outer plexiform layer of the retina resul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00346983
Start Date
June 1 2006
End Date
May 1 2007
Last Update
May 12 2008
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287