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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: Completed Phase 3 study, sponsored by Chromaderm.
NCT00133952 is a Phase 3 study that has completed, run by Chromaderm. The registered enrollment target is 309 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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 participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).
Interventions
- DRUG Placebo
- DRUG Ruboxistaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2005-08 |
| Est. Completion | 2011-07 |
| Phase | Phase 3 |
What the finished NCT00133952 record still lists
NCT00133952 is an interventional study that assigns participants to a tested intervention. The registered 309 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00133952 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00133952's enrollment target sits among peer trials
309 1109th of 2000 higher than 889 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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