NCT00758628

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Bp Consulting, Inc · Network
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bromefenac	Bromfenac BID 3 months
DRUG	Blink	Blink BID for 3 months

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-09-25
• Last updated: 2009-09-04

Locations

1 site across 1 country: United States