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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 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 660 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01627249
The ClinicalTrials.gov registry entry for NCT01627249 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 660 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 3 interventions - of which 2.0 mg intravitreal aflibercept is the first listed.
NCT01627249 reports 0 study locations.
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.
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