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NCT00336323 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)
A Phase 2 study of Diabetic Retinopathy, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 121
- Enrollment target
- 20
- Study locations
NCT00336323: Completed Phase 2 study of Diabetic Retinopathy, sponsored by Jaeb Center for Health Research.
NCT00336323 is a Phase 2 study of Diabetic Retinopathy that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 121 participants, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00336323, a Phase 2 study of Diabetic Retinopathy, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 121 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial. In addition, this study will provide preliminary data on the safety of intravitreally administered Avastin in subjects with DME.
Primary Outcome
Change in central subfield retinal thickness from baseline measured on Optical Coherence Tomography (OCT). OCT images were obtained at each visit following pupil dilation by a certified operator using the OCT3 machine (Carl Zeiss Meditec Inc., Dublin, CA). Scans were 6 mm length and included the 6 radial line pattern for quantitative measures and the cross hair pattern (6-12 to 9-3 o'clock) for qualitative assessment of retinal morphology. The OCT scans were sent to the DRCR.net Reading Center f
Conditions Studied
Interventions
- DRUG Bevacizumab
- PROCEDURE Laser Photocoagulation
Study Locations (20)
California
- Loma Linda University Health Care, Dept. of Ophthalmology - Loma Linda
- Southern California Desert Retina Consultants, MC - Palm Springs
- California Retina Consultants - Santa Barbara
- Bay Area Retina Associates - Walnut Creek
Florida
- Retina Vitreous Consultants - Fort Lauderdale
- Central Florida Retina Institute - Lakeland
Indiana
- Raj K. Maturi, M.D., P.C. - Indianapolis
- American Eye Institute - New Albany
Kentucky
- Retina and Vitreous Associates of Kentucky - Lexington
- Paducah Retinal Center - Paducah
Maryland
- Elman Retina Group, P.A. - Baltimore
- Retina Consultants of Delmarva, P.A. - Salisbury
Massachusetts
- Ophthalmic Consultants of Boston - Boston
- Joslin Diabetes Center - Boston
North Carolina
- Charlotte Eye, Ear, Nose and Throat Assoc., PA - Charlotte
- Wake Forest University Eye Center - Winston-Salem
Georgia
- Southeast Retina Center, P.C. - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-02 |
| Phase | Phase 2 |
What the finished NCT00336323 record still lists
NCT00336323 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 1,674-participant average among 57 other Diabetic Retinopathy trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Diabetic Retinopathy appearing as the primary indexed condition, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00336323 names 20 study sites across 11 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT00336323 about?
NCT00336323 is a clinical study titled "A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin)". This study will provide preliminary data on the dose and dose interval related effects of intravitreally administered Avastin on retinal thickness and visual acuity in subjects with Diabetic Macular Edema (DME) to aid in planning a phase 3 trial. In addition, this study will provide preliminary dat...
What is the current status of trial NCT00336323?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 121 participants. The study started on 2006-06. Estimated completion is 2008-02.
What conditions does trial NCT00336323 study?
This clinical trial studies the following conditions: Diabetic Retinopathy.
What interventions are being tested in trial NCT00336323?
The interventions under investigation include: Bevacizumab (DRUG), Laser Photocoagulation (PROCEDURE).
Who is sponsoring clinical trial NCT00336323?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00336323 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Retinopathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00336323's enrollment target sits among peer trials
121 35th of 57 higher than 23 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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