- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358423
The Effect of Macugen in Patients With Chronic, Post-Operative Cystoid Macular Edema
Pilot Study of the Effect of Pegaptanib Sodium in Patients With Chronic, Post-Operative Cystoid Macular Edema
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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-
Maryland
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Baltimore, Maryland, United States, 21287
- The Johns Hopkins Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
0.3 mg/0.1 ml intravitreal injection, every 6 weeks, up to a total of 3 injections
Other Names:
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Placebo Comparator: B
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Sham injections, every 6 weeks, up to a total of 3 sham injections
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of subjects improving >/= 15 letters (3 lines) of best-corrected distance visual acuity at 18 weeks after initiation of pegaptanib. Distribution of visual acuity changes at 18 weeks after initiation of pegaptanib
Time Frame: 18 weeks after enrollment
|
18 weeks after enrollment
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Distribution of absolute levels of distance visual acuity at 18 weeks after initiation of pegaptanib
Time Frame: 18 weeks after enrollment
|
18 weeks after enrollment
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Analysis of time to 15 letter improvement of best-corrected distance visual acuity through 18 weeks after initiation of pegaptanib using a 2-state stochastic model to account for events and recoveries from events
Time Frame: 18 weeks after enrollment
|
18 weeks after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of decrease in retinal thickness by OCT at 18 weeks after initiation of pegaptanib
Time Frame: 18 weeks after enrollment
|
18 weeks after enrollment
|
Analysis of improvement of fluorescein leakage seen on fluorescein angiography at 18 weeks after initiation of pegaptanib
Time Frame: 18 weeks after enrollment
|
18 weeks after enrollment
|
Additional changes 12 weeks after discontinuation of pegaptanib (6 months after study entry)
Time Frame: 6 months after enrollment
|
6 months after enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Diana V. Do, MD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00001702
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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