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NCT01934556 · ClinicalTrials.gov registry record · Phase 1
A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema
A Phase 1 study of Diabetic Macular Edema, sponsored by Palmetto Retina Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 3
- Study locations
NCT01934556: Completed Phase 1 study of Diabetic Macular Edema, sponsored by Palmetto Retina Center.
NCT01934556 is a Phase 1 study of Diabetic Macular Edema that has completed, run by Palmetto Retina Center. The registered enrollment target is 150 participants, below the 3,792-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (96% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01934556, a Phase 1 study of Diabetic Macular Edema, has completed, sponsored by Palmetto Retina Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabetes.
Primary Outcome
Mean change in ETDRS (Early Treatment in Diabetic Retinopathy Study) visual acuity at 24 months (week 92-week 107) from Day 0. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning"
Conditions Studied
Interventions
- DRUG Ranibizumab 0.3 mg intravitreal injection
- DEVICE Guided Laser Photocoagulation
Study Locations (3)
California
- Retina-Vitreous Associates Medical Group - Beverly Hills
South Carolina
- Palmetto Retina Center - West Columbia
Texas
- Retina Consultants of Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-11 |
| Est. Completion | 2018-04 |
| Phase | Phase 1 |
What the finished NCT01934556 record still lists
NCT01934556 is an interventional study that assigns participants to a tested intervention. The registered 150 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 2 interventions - of which Ranibizumab 0.3 mg intravitreal injection is the first listed.
NCT01934556 reports a single indexed study location in California, South Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT01934556 about?
NCT01934556 is a clinical study titled "A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema". The purpose of this research study is to determine if a "Treat and Extend" regimen (increasing the time between visits when the disease is stable and not getting worse) of Ranibizumab 0.3 mg injections inside the eye is safe and effective at treating patients with swelling of the retina from diabete...
What is the current status of trial NCT01934556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2013-11. Estimated completion is 2018-04.
What conditions does trial NCT01934556 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT01934556?
The interventions under investigation include: Ranibizumab 0.3 mg intravitreal injection (DRUG), Guided Laser Photocoagulation (DEVICE).
Who is sponsoring clinical trial NCT01934556?
This trial is sponsored by Palmetto Retina Center, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01934556 being conducted?
This trial has 3 study locations across California, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01934556's enrollment target sits among peer trials
150 26th of 63 higher than 38 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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