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NCT00758628 · ClinicalTrials.gov registry record · Phase 4
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, sponsored by Bp Consulting.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT00758628: Completed Phase 4 study, sponsored by Bp Consulting.
NCT00758628 is a Phase 4 study that has completed, run by Bp Consulting. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00758628, a Phase 4 study, has completed, sponsored by Bp Consulting.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- DRUG Bromefenac
- DRUG Blink
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-05 |
| Phase | Phase 4 |
What the finished NCT00758628 record still lists
NCT00758628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Bromefenac is the first listed.
NCT00758628 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00758628 about?
NCT00758628 is a clinical study titled "Randomized, Double Blind Trial of Bromfenac BID (0.09%) as an Adjunct to Argon Laser Therapy in the Treatment of Diabetic Macular Edema.". : 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 Diabe...
What is the current status of trial NCT00758628?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2008-08. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00758628?
The interventions under investigation include: Bromefenac (DRUG), Blink (DRUG).
Who is sponsoring clinical trial NCT00758628?
This trial is sponsored by Bp Consulting, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00758628's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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