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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.

This study has been completed.
Sponsor:
Information provided by:
Bp Consulting, Inc
ClinicalTrials.gov Identifier:
NCT00758628
First received: September 22, 2008
Last updated: September 3, 2009
Last verified: September 2009
  Purpose

: 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 Intervention Phase
Diabetic Macular Edema
Drug: Bromefenac
Drug: Blink
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Bp Consulting, Inc:

Primary Outcome Measures:
  • Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Re-treatment rate and interval between successive sessions of ALT v/s Control Arm. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bromfenac
Drug: Bromefenac
Bromfenac BID 3 months
Other Name: Xibrom
Placebo Comparator: 2
Blink
Drug: Blink
Blink BID for 3 months
Other Name: Blink tears

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758628

Locations
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
  More Information

No publications provided

Responsible Party: Kenneth Wald, Retina Eye Associates of New York
ClinicalTrials.gov Identifier: NCT00758628     History of Changes
Other Study ID Numbers: 01
Study First Received: September 22, 2008
Last Updated: September 3, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Edema
Macular Edema
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Bromfenac
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014