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NCT01909791 · ClinicalTrials.gov registry record · Phase 3
Treatment for CI-DME in Eyes With Very Good VA Study
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 702
- Enrollment target
NCT01909791: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT01909791 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 702 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01909791, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 702 participants
- Enrollment target
Study Summary
Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or worse (approximate Snellen equivalent of 20/32 or worse) were eligible. Eyes that have central-involved DME with "good" visual acuity (20/25 or better) have not been addressed systematically by recent studies for treatment of DME. Baseline cohort characteristics from the Early Treatment Diabetic Retinopathy Study (ETDRS) suggest that a substantial percentage of eyes with central-involved DME may retain good vision. The investigators do not know definitively whether eyes with central-involved DME and good vision do better with anti-VEGF (vascular endothelial growth factor) (e.g. aflibercept) therapy initially, or focal/grid laser treatment or observation initially followed by anti-VEGF only if vision worsens. The primary objective of the protocol is to compare the % of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central-involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better (electronic-ETDRS letter score of 79 or better) that receive (1) prompt focal/grid photocoagulation + deferred anti-VEGF, (2) observation + deferred anti-VEGF, or (3) prompt anti-VEGF. Secondary objectives include: * Comparing other visual acuity outcomes between treatment groups, such as the percent of eyes with at least 5, 10 and 15 letter losses in visual acuity from baseline mean visual acuity, percent of eyes with at least 5 letter gain in visual acuity from baseline, mean visual acuity, mean change in visual acuity, adjusted for baseline mean visual acuity * For eyes randomized to deferred anti-VEGF, the percentage of eyes needing anti-VEGF treatment * Comparing optical coherence tomograp
Primary Outcome
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/12) to 0 letters (Snellen equivalent of 20/800).
Interventions
- DRUG Prompt aflibercept
- PROCEDURE Deferred laser
- DRUG Deferred aflibercept
- PROCEDURE Prompt Laser
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2013-10 |
| Est. Completion | 2018-09-11 |
| Phase | Phase 3 |
What the finished NCT01909791 record still lists
NCT01909791 is an interventional study that assigns participants to a tested intervention. The registered 702 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 4 interventions - of which Prompt aflibercept is the first listed.
NCT01909791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01909791 about?
NCT01909791 is a clinical study titled "Treatment for CI-DME in Eyes With Very Good VA Study". Although multiple studies have clearly demonstrated that ranibizumab therapy is more effective than laser alone for vision gain and avoiding vision loss in patients with central-involved Diabetic Macular Edema (DME), only eyes with poor visual acuity, such as a visual acuity letter score of 78 or wo...
What is the current status of trial NCT01909791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2013-10. Estimated completion is 2018-09-11.
What interventions are being tested in trial NCT01909791?
The interventions under investigation include: Prompt aflibercept (DRUG), Deferred laser (PROCEDURE), Deferred aflibercept (DRUG), Prompt Laser (PROCEDURE).
Who is sponsoring clinical trial NCT01909791?
This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01909791's enrollment target sits among peer trials
702 506th of 2000 higher than 1,495 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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