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NCT00133952 · ClinicalTrials.gov registry record · Phase 3
Effect of Ruboxistaurin on Clinically Significant Macular Edema
A Phase 3 study, sponsored by Chromaderm.
- Completed
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
NCT00133952 is a Phase 3 study that has completed, run by Chromaderm. The registered enrollment target is 309 participants.
The verdict
NCT00133952, a Phase 3 study, has completed, sponsored by Chromaderm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
Study Summary
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.
Interventions
- DRUG Placebo
- DRUG Ruboxistaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2005-08 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00133952
The ClinicalTrials.gov registry entry for NCT00133952 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chromaderm, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00133952 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00133952 about?
NCT00133952 is a clinical study titled "Effect of Ruboxistaurin on Clinically Significant Macular Edema". The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Earl...
What is the current status of trial NCT00133952?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2005-08. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00133952?
The interventions under investigation include: Placebo (DRUG), Ruboxistaurin (DRUG).
Who is sponsoring clinical trial NCT00133952?
This trial is sponsored by Chromaderm, which has 9 total clinical trials registered on ClinicalTrials.gov.
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