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NCT00604383 · ClinicalTrials.gov registry record · Phase 3
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
A Phase 3 study, sponsored by Chromaderm.
- Completed
- Registry status
- Phase 3
- Development phase
- 685
- Enrollment target
NCT00604383: Completed Phase 3 study, sponsored by Chromaderm.
NCT00604383 is a Phase 3 study that has completed, run by Chromaderm. The registered enrollment target is 685 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (11% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00604383, a Phase 3 study, has completed, sponsored by Chromaderm.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 685 participants
- Enrollment target
Study Summary
This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
Primary Outcome
SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (n
Interventions
- DRUG placebo
- DRUG ruboxistaurin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 685 participants |
| Start Date | 2001-03 |
| Est. Completion | 2005-06 |
| Phase | Phase 3 |
What the finished NCT00604383 record still lists
NCT00604383 is an interventional study that assigns participants to a tested intervention. The registered 685 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 (11% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00604383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00604383 about?
NCT00604383 is a clinical study titled "Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study". This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.
What is the current status of trial NCT00604383?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 685 participants. The study started on 2001-03. Estimated completion is 2005-06.
What interventions are being tested in trial NCT00604383?
The interventions under investigation include: placebo (DRUG), ruboxistaurin (DRUG).
Who is sponsoring clinical trial NCT00604383?
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 NCT00604383's enrollment target sits among peer trials
685 527th of 2000 higher than 1,473 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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