Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Bp Consulting. The registered enrollment target is 50 participants.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00758628
The ClinicalTrials.gov registry entry for NCT00758628 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bp Consulting, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bromefenac is the first listed.
NCT00758628 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.