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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00758628
Recruitment Status : Completed
First Posted : September 25, 2008
Last Update Posted : September 4, 2009
Information provided by:
Bp Consulting, Inc

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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Bromefenac Drug: Blink Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : August 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: 1
Drug: Bromefenac
Bromfenac BID 3 months
Other Name: Xibrom

Placebo Comparator: 2
Drug: Blink
Blink BID for 3 months
Other Name: Blink tears

Primary Outcome Measures :
  1. Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Re-treatment rate and interval between successive sessions of ALT v/s Control Arm. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00758628

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United States, New York
Retina Eye Associates of New York
140 East 80th street New York, NY 10075, New York, United States, 10075
Sponsors and Collaborators
Bp Consulting, Inc
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Responsible Party: Kenneth Wald, Retina Eye Associates of New York Identifier: NCT00758628    
Other Study ID Numbers: 01
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases