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

: 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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Bromefenac; Drug: Blink

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • 140 East 80th street New York, NY 10075, New York, United States, 10075
      • Retina Eye Associates of New York

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Bromfenac	Drug: Bromefenac; Bromfenac BID 3 months; Other Names: Xibrom
Placebo Comparator: 2; Blink	Drug: Blink; Blink BID for 3 months; Other Names: Blink tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Re-treatment rate and interval between successive sessions of ALT v/s Control Arm.	3 months

Collaborators and Investigators

• Sponsor: Bp Consulting, Inc

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Estimate): September 4, 2009
• Last Update Submitted That Met QC Criteria: September 3, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: 01 (Miami VAHS)