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NCT01627249 · ClinicalTrials.gov registry record · Phase 3
Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema
A Phase 3 study, sponsored by Jaeb Center for Health Research.
- Completed
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
NCT01627249: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.
NCT01627249 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 660 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01627249, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
Study Summary
Although multiple studies have suggested that treatment with ranibizumab is safe and efficacious and superior to focal/grid laser alone for patients with center-involved diabetic macular edema (DME), there may be barriers in place to widespread adoption of ranibizumab use given its high cost per dose and the need for multiple treatments over time. Prioritizing resources from a public health policy perspective could be easier if more precise estimates regarding the risks and benefits of other anti-vascular endothelial growth factor (anti-VEGF) therapies were available, especially when the difference in costs could be billions of dollars over just a few years. Thus, there is a clear rationale at this time to explore potential anti-VEGF alternatives to ranibizumab that might prove to be as or more efficacious, might deliver equally lasting or longer-lasting treatment effects, and cost substantially less. Of the potentially available alternative anti-VEGF agents for this trial, bevacizumab and aflibercept are the best candidates for a direct comparison study. Bevacizumab shares the most similar molecular structure, costs far less, and is widely available. Furthermore, there is already preliminary evidence to suggest that it may be efficacious in the treatment of DME and it is already being widely used for this indication. Although aflibercept has a similar cost per unit dose to ranibizumab, it has the potential to decrease treatment burden and associated cost. If results from a comparative trial demonstrate improved efficacy or suggest similar efficacy of bevacizumab or aflibercept over ranibizumab, this information might give clinicians scientific rationale to substitute either one of these drugs for ranibizumab in the treatment of DME, and might thereby have substantial implications for public policy in terms of future estimates of health care dollars and possibly number of treatments necessary for anti-VEGF treatment of diabetic macular disease. Because of its avail
Primary Outcome
Visual Acuity was measured with the Electronic Early Treatment Study (E-ETDRS) visual acuity test. Unit of measure is based on the E-ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Interventions
- DRUG 2.0 mg intravitreal aflibercept
- DRUG 1.25 mg intravitreal bevacizumab
- DRUG 0.3 mg intravitreal ranibizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2012-08 |
| Est. Completion | 2019-04-18 |
| Phase | Phase 3 |
What the finished NCT01627249 record still lists
NCT01627249 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (15% lower).
The record links to 0 conditions, and to 3 interventions - of which 2.0 mg intravitreal aflibercept is the first listed.
NCT01627249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01627249 about?
NCT01627249 is a clinical study titled "Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema". Although multiple studies have suggested that treatment with ranibizumab is safe and efficacious and superior to focal/grid laser alone for patients with center-involved diabetic macular edema (DME), there may be barriers in place to widespread adoption of ranibizumab use given its high cost per dos...
What is the current status of trial NCT01627249?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2012-08. Estimated completion is 2019-04-18.
What interventions are being tested in trial NCT01627249?
The interventions under investigation include: 2.0 mg intravitreal aflibercept (DRUG), 1.25 mg intravitreal bevacizumab (DRUG), 0.3 mg intravitreal ranibizumab (DRUG).
Who is sponsoring clinical trial NCT01627249?
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 NCT01627249's enrollment target sits among peer trials
660 556th of 2000 higher than 1,440 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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