Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab, and Ranibizumab for Diabetic Macular Edema
Status:
Completed
Trial end date:
2019-04-18
Target enrollment:
Participant gender:
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 availability and lower cost, bevacizumab is already currently in widespread
clinical use for treatment of DME despite the lack of FDA approval for this indication. Thus,
a clinical trial that suggested whether bevacizumab could be used as a safe and efficacious
alternative to ranibizumab could substantially impact nationwide practice patterns for
treatment of DME by either validating the current use of bevacizumab or by demonstrating
improved outcomes with ranibizumab or aflibercept treatment for DME.
Study Objective The primary objective of the proposed research is to compare the efficacy and
safety of (1) intravitreal aflibercept, (2) intravitreal bevacizumab, and (3) intravitreal
ranibizumab when given to treat central-involved DME in eyes with visual acuity of 20/32 to
20/320.
Phase:
Phase 3
Details
Lead Sponsor:
Jaeb Center for Health Research
Collaborators:
Genentech, Inc. National Eye Institute (NEI) Regeneron Pharmaceuticals