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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758628
• Other study ID #: 01
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2008
• Last updated: September 3, 2009
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: September 2009
• Source: Bp Consulting, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Bromefenac
Bromfenac BID 3 months
• Blink
Blink BID for 3 months

Locations

Country	Name	City	State
United States	Retina Eye Associates of New York	140 East 80th street New York, NY 10075	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bp Consulting, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation.		3 months	No
Secondary	Re-treatment rate and interval between successive sessions of ALT v/s Control Arm.		3 months	No