Back to resultsRandomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bromefenac
Blink
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility 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.
Sites / Locations
- Retina Eye Associates of New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Bromfenac
Blink
Outcomes
Primary Outcome Measures
Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation.
Secondary Outcome Measures
Re-treatment rate and interval between successive sessions of ALT v/s Control Arm.
Full Information
NCT ID
NCT00758628
First Posted
September 22, 2008
Last Updated
September 3, 2009
Sponsor
Bp Consulting, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00758628
Brief Title
Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.
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 Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bp Consulting, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bromfenac
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Blink
Intervention Type
Drug
Intervention Name(s)
Bromefenac
Other Intervention Name(s)
Xibrom
Intervention Description
Bromfenac BID 3 months
Intervention Type
Drug
Intervention Name(s)
Blink
Other Intervention Name(s)
Blink tears
Intervention Description
Blink BID for 3 months
Primary Outcome Measure Information:
Title
Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Re-treatment rate and interval between successive sessions of ALT v/s Control Arm.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Retina Eye Associates of New York
City
140 East 80th street New York, NY 10075
State/Province
New York
ZIP/Postal Code
10075
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.
We'll reach out to this number within 24 hrs