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NCT03397264 · ClinicalTrials.gov registry record · Phase 1
A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema
A Phase 1 study of Diabetic Macular Edema, sponsored by Opthea Limited.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT03397264: Completed Phase 1 study of Diabetic Macular Edema, sponsored by Opthea Limited.
NCT03397264 is a Phase 1 study of Diabetic Macular Edema that has completed, run by Opthea Limited. The registered enrollment target is 153 participants, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03397264, a Phase 1 study of Diabetic Macular Edema, has completed, sponsored by Opthea Limited.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study Summary
A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.
Primary Outcome
Safety and Tolerability will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events and CTC v4.0 (if available, otherwise protocol defined grading were used)
Conditions Studied
Interventions
- BIOLOGICAL Aflibercept
- BIOLOGICAL OPT-302
- OTHER Sham intravitreal injection
Study Locations (20)
California
- Opthea Investigational Site - Bakersfield
- Opthea Investigational Site - Beverly Hills
- Opthea Investigational Site - Redlands
- Opthea Investigational Site - Sacramento
- Opthea Investigational Site - Santa Ana
Florida
- Opthea Investigational Site - Boynton Beach
- Opthea Investigational Site - Fort Myers
- Opthea Investigational Site - Melbourne
- Opthea Investigational Site - Pensacola
- Opthea Investigational Site - St. Petersburg
Nevada
- Opthea Investigational Site - Las Vegas
- Opthea Investigational Site - Reno
Arizona
- Opthea Investigational Site - Phoenix
Colorado
- Opthea Investigational Site - Colorado Springs
Georgia
- Opthea Investigational Site - Augusta
Indiana
- Opthea Investigational Site - Indianapolis
Iowa
- Opthea Investigational Site - Des Moines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2018-01-16 |
| Est. Completion | 2020-06-11 |
| Phase | Phase 1 |
What the finished NCT03397264 record still lists
NCT03397264 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 3 interventions - of which Aflibercept is the first listed.
NCT03397264 names 20 study sites across 11 states, led by California, Florida, Nevada.
Frequently Asked Questions
What is clinical trial NCT03397264 about?
NCT03397264 is a clinical study titled "A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema". A two part, multi-center study consisting of a Phase 1b open label, sequential dose escalation followed by a Phase 2a randomized, double-masked, dose expansion evaluating OPT-302 in combination with aflibercept in participants with persistent central-involved Diabetic Macular Edema.
What is the current status of trial NCT03397264?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2018-01-16. Estimated completion is 2020-06-11.
What conditions does trial NCT03397264 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT03397264?
The interventions under investigation include: Aflibercept (BIOLOGICAL), OPT-302 (BIOLOGICAL), Sham intravitreal injection (OTHER).
Who is sponsoring clinical trial NCT03397264?
This trial is sponsored by Opthea Limited, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03397264 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03397264's enrollment target sits among peer trials
153 24th of 63 higher than 40 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema 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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