Status:
COMPLETED
Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.
Lead Sponsor:
Bp Consulting, Inc
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
: The objective of this study is to determine if bromfenac reduces diabetic macular edema (DME) as an adjunct to argon laser therapy (ALT). Leading cause of Blindness in the working-aged population in...
Eligibility Criteria
Inclusion
- Male or female \>18 years of age scheduled to undergo argon laser therapy. Patients with diabetic macular edema (DME) and/or proliferative diabetic retinopathy as evidenced by ophthalmic examination and diagnostics, with either central macular or peripheral involvement.
- Female subjects of childbearing potential must have a normal menstrual cycle and a negative urine pregnancy test result prior to study entry. Women must be either post-menopausal or surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oopherectomy), or women of childbearing potential must use an effective method of birth control. Acceptable methods of birth control include hormonal contraceptives (i.e. pill, patch, ring, injection, implant), intrauterine device (IUD), diaphragm with spermicide or condom with spermicide.
- The incidence of DME will be determined by 2 methods:
- Diagnosis of clinical DME can be made by the masked investigator during the study based on the investigator's medical opinion and expertise
- Diagnosis of DME by a masked clinical specialist will review all Optical Coherence Tomography (OCT) after conclusion of study. The diagnosis will be stratified into 3 categories:
- Definite DME: retinal swelling or blurred vision.
- Probable DME: Presence of changes in retinal swelling or blurred vision noted from baseline to follow up.
- Possible DME: subtle to moderate changes in retinal swelling or blurred vision noted.
- Best Corrected Visual Acuity (BCVA) ranging between 20/40 and 20/400.
Exclusion
- Patients who received intra-vitreal/sub-tenon corticosteroid injections.
- Macular scarring/fibrosis, advanced cataract, advanced glaucoma, retinal pigment epithelial detachments (RPEDs).
- Other causes affecting visual improvement.
- Allergy to bromfenac or NSAIDS.
- Sensitivity to sulfite.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00758628
Start Date
August 1 2008
End Date
May 1 2009
Last Update
September 4 2009
Active Locations (1)
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1
Retina Eye Associates of New York
140 East 80th Street New York, NY 10075, New York, United States, 10075