Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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. |
- Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 |
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 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 Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Bromfenac Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013