Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 702 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01909791
The ClinicalTrials.gov registry entry for NCT01909791 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 702 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Prompt aflibercept is the first listed.
NCT01909791 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.