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NCT00198510 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage
A Phase 3 study of Diabetic Retinopathy and Vitreous Hemorrhage, sponsored by Bausch & Lomb Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 750
- Enrollment target
- 20
- Study locations
NCT00198510: Completed Phase 3 study of Diabetic Retinopathy and Vitreous Hemorrhage, sponsored by Bausch & Lomb Incorporated.
NCT00198510 is a Phase 3 study of Diabetic Retinopathy and Vitreous Hemorrhage that has completed, run by Bausch & Lomb Incorporated. The registered enrollment target is 750 participants, below the 1,663-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00198510, a Phase 3 study of Diabetic Retinopathy and Vitreous Hemorrhage, has completed, sponsored by Bausch & Lomb Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 750 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
Primary Outcome
Laser treatment of underlying cause of vitreous hemorrhage, or other surgical treatment, or documented evidence of macula \& at least 180 degrees of vitreous base, that vitreous hemorrhage cause is resolved
Conditions Studied
Interventions
- DRUG Vitrase
Study Locations (20)
California
- Retina Vitreous Associates Medical Group - Beverly Hills
- Maria E. Castillejos, MD - Chula Vista
- Natural Vision - Fresno
- Eye Medical Center of Fresno - Fresno
- Jerry Sebag, MD - Huntington Beach
- University of California, Irvine - Irvine
- California VitreRetinal Center - Menlo Park
- Southern California Desert Retina Consultants - Palm Springs
- Retinal Consultants - Sacramento
- H. Richard McDonald, MD - San Francisco
- Santa Clara Valley Medical Centre - San Jose
- Robert L. Avery, MD - Santa Barbara
- Olive View/UCLA Medical Center - Sylmar
Colorado
- Retina Consultants of Southern Colorado - Colorado Springs
- University of Colorado Health Sciences Center - Denver
Connecticut
- Danbury Eye Physicians & Surgeons - Danbury
- New England Retina Associates - Hamden
Florida
- Florida Eye Clinic - Altamonte Springs
- Eye Centers of Florida - Fort Myers
Arizona
- Retina Centers, PC - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 1998-11 |
| Est. Completion | 2003-03 |
| Phase | Phase 3 |
What the finished NCT00198510 record still lists
NCT00198510 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, below the 1,663-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (55% lower).
The record links to 2 conditions, with Diabetic Retinopathy appearing as the primary indexed condition, and to 1 intervention - of which Vitrase is the first listed.
NCT00198510 names 20 study sites across 5 states, led by California, Colorado, Connecticut.
Frequently Asked Questions
What is clinical trial NCT00198510 about?
NCT00198510 is a clinical study titled "Safety and Efficacy Study of Vitrase for Clearance of Severe Vitreous Hemorrhage". The purpose of this study is to determine if intravitreal injection of Vitrase (ovine hyaluronidase) clears vitreous hemorrhage
What is the current status of trial NCT00198510?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 1998-11. Estimated completion is 2003-03.
What conditions does trial NCT00198510 study?
This clinical trial studies the following conditions: Diabetic Retinopathy, Vitreous Hemorrhage.
What interventions are being tested in trial NCT00198510?
The interventions under investigation include: Vitrase (DRUG).
Who is sponsoring clinical trial NCT00198510?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00198510 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00198510's enrollment target sits among peer trials
750 9th of 57 higher than 49 of 57 other Diabetic Retinopathy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Retinopathy 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.
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