Status:
WITHDRAWN
Pilot Study of the Effect of Topical Bromfenac Ophthalmic Solution 0.09%in Patients With Acute Post-operative Cystoid Macular Edema.
Lead Sponsor:
Johns Hopkins University
Conditions:
Cystoid Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research is being done to look at the effects of Bromfenac, also called Xibrom for the treatment of swelling in the retina (the light sensitive tissue in the back of the eye) called "macular edem...
Detailed Description
Over 2.5 million cataract surgeries are performed yearly in the United States. Despite advances in cataract surgery, cystoid macular edema (CME) is the most common cause of loss of vision after catara...
Eligibility Criteria
Inclusion
- Adults (ages 18 years or older)
- Best-corrected visual acuity 20/40 or worse
- Pseudophakic CME in the study eye with onset at least three weeks and no more than four months after cataract surgery, as document on fluorescein angiography and/or OCT (central subfield \>/= 250 microns)
- Agree to avoid disallowed medications (including ocular, topical, or systemic NSAIDs; ocular, topical, or systemic corticosteroids; ocular prostaglandin analogs) throughout the duration of the study. Agree to a 14 day washout period prior to enrollment if currently using a disallowed medication.
Exclusion
- History of a known hypersensitivity to bromfenac, or any component of the test agents and/or "procedural" medications (such as anesthetic, dilating drops, fluorescein, etc)
- History of pre-existing macular disease that confounds and/or precludes the evaluation of cystoid macular edema (including but not limited to macular hole, epiretinal membrane with pseudohole, diabetic macular edema, neovascular age-related macular degeneration, acute posterior uveitis)
- CME due to other etiologies such as vein occlusion
- Use of a topical ophthalmic prostaglandin analog within 14 days prior to enrollment, i.e., the subject does not agree to a 14 day washout period prior to enrollment.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00438243
Start Date
May 1 2008
End Date
September 1 2010
Last Update
July 4 2016
Active Locations (1)
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1
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287