Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.

NCT ID: NCT00758628

Last Updated: 2009-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-05-31

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 the United States. 60% of patients with Type-II DM, and nearly all with Type-I DM progress to Diabetic Retinopathy (DR) in twenty years. Diabetic Macular Edema is the principal cause of vision loss in DR. Approximately 50% of patients with DME will experience a loss of >=2 lines of best-corrected visualacuity (VA) after 2 years of follow-up. The pathogenesis of DME is multifactorial and complex, but intervention stratagem have tended to be singular. Photocoagulation laser applied directly to leaking microaneurysms and a "grid" of laser has been the mainstays of treatment since the publication of the Early Treatment Diabetic Retinopathy Study (ETDRS). This landmark clinical trial was an NIH sponsored, multicenter, controlled study that demonstrated efficacy of laser for diabetic macular edema. It also demonstrated that 20% of patients did not respond. Recent efforts to improve the results are focusing on pharmaceutical interventions injected into the vitreous cavity. The route of administration and lack of substantiated efficacy are problematic.

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Bromfenac

Group Type: ACTIVE_COMPARATOR

Bromefenac

Intervention Type: DRUG

Bromfenac BID 3 months

2

Blink

Group Type: PLACEBO_COMPARATOR

Blink

Intervention Type: DRUG

Blink BID for 3 months

Interventions

Bromefenac

Bromfenac BID 3 months

Intervention Type: DRUG

Blink

Blink BID for 3 months

Intervention Type: DRUG

Other Intervention Names

Xibrom; Blink tears

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bp Consulting, Inc

NETWORK

Sponsor Role: lead

Responsible Party

Retina Eye Associates of New York

Locations

Retina Eye Associates of New York

140 East 80th Street New York, NY 10075, New York, United States

Countries

United States

Other Identifiers

01

Identifier Type: -

Identifier Source: org_study_id