Diabetic Macular EdemaPhase 4NCT00758628
Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.
A Phase 4 study testing Bromefenac and Blink in people with Diabetic Macular Edema, run by Bp Consulting, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Bromefenac and Blink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Eye Associates of New York
140 East 80th Street New York, NY 10075, New York, 10075
About this study
: 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.
- Conditions
- Diabetic Macular Edema
- Being tested
- Bromefenac, Blink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromefenacDrug
Also called Xibrom
Bromfenac BID 3 months
BlinkDrug
Also called Blink tears
Blink BID for 3 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bromfenac Receives: Drug: Bromefenac |
| 2 | Placebo comparator | Blink Receives: Drug: Blink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation.
Measured: 3 months
Secondary outcomes (1)
Re-treatment rate and interval between successive sessions of ALT v/s Control Arm.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bp Consulting, Inc
- Sponsor type
- Research network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758628
- Sponsor's protocol ID
- 01
- Status last verified
- Sep 2009
- First submitted
- 22 Sep 2008
- Last updated
- 4 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00758628
- Acronym / sponsor ID
- 01
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bp Consulting, IncResearch network
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: BromefenacBromfenac |
| 2 | Placebo comparator | Drug: BlinkBlink |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Best Corrected Visual Acuity (BCVA) ranging between 20/40 and 20/400.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BromefenacAlso: XibromBromfenac BID 3 months | Drug | 1 |
| BlinkAlso: Blink tearsBlink BID for 3 months | Drug | 2 |
Primary outcome
Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation.
Time frame: 3 months
1 secondary outcome
Re-treatment rate and interval between successive sessions of ALT v/s Control Arm.
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bromefenac and Blink in people with Diabetic Macular Edema, run by Bp Consulting, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular/Foveal Thickness (on OCT) v/s Control Arm, compared to baseline evaluation. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2009.