DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME

Completed · Phase 3

Conditions studied: Diabetic Macular Edema

In brief

Both aflibercept and bevacizumab have been shown to improve vision in eyes with DME. In eyes with DME and at least moderate vision loss, both aflibercept and bevacizumab were also shown to be successful in many eyes. However, aflibercept was shown to be more effective at improving vision, on average, at 1 year and at 2 years. Due to the large cost difference between the two drugs, many clinicians and patients are choosing to initiate treatment with bevacizumab and then switch to aflibercept depending on the eye's response to bevacizumab treatment. However, there is no scientific evidence that this treatment strategy is as effective at improving vision as initiating treatment with aflibercept. Patients and clinicians do not know if this approach ultimately has deleterious effects on visual acuity. If starting with aflibercept is not better than starting with bevacizumab and switching to aflibercept if needed, the potential cost savings to future patients and the health care system would be substantial. However, if starting with aflibercept is better, then patients, clinicians, and health care providers can make informed decisions for how to best treat patients with DME and at least moderate vision loss. Study Objectives To compare the efficacy of intravitreous aflibercept with intravitreous bevacizumab + deferred aflibercept if needed in eyes with CI DME and moderate vision loss

Key facts

Study ID

NCT03321513

Run by

Jaeb Center for Health Research

People needed

270

Starts

2017-12-07

Expected to finish

2021-12-22

Last updated by the study team

2024-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Macula & Retina Institute — Glendale, California, United States
• Loma Linda University Health Care, Department of Ophthalmology — Loma Linda, California, United States
• East Bay Retina Consultants, Inc — Oakland, California, United States
• National Ophthalmic Research Institute — Fort Myers, Florida, United States
• Florida Retina Institute-Jacksonville — Jacksonville, Florida, United States
• Florida Retina Consultants — Lakeland, Florida, United States
• Retina Macula Specialists of Miami — Miami, Florida, United States
• Central Florida Retina — Orlando, Florida, United States
• Florida Retina Institute — Orlando, Florida, United States
• Southeast Eye Institute, P.A. dba Eye Associates of Pinellas — Pinellas Park, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Retina Associates of Sarasota — Sarasota, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Retina Associates of Florida, LLC — Tampa, Florida, United States
• Retina Specialists of Tampa — Wesley Chapel, Florida, United States
• Southeast Retina Center, P.C. — Augusta, Georgia, United States
• Thomas Eye Group — Sandy Springs, Georgia, United States
• Illinois Retina Associates, S.C. — Oak Park, Illinois, United States
• Springfield Clinic, LLP — Springfield, Illinois, United States
• Raj K. Maturi, M.D., P.C. — Indianapolis, Indiana, United States
• John-Kenyon American Eye Institute — New Albany, Indiana, United States
• Mid-America Retina Consultants, P.A. — Overland Park, Kansas, United States
• Retina Associates, P.A. — Shawnee Mission, Kansas, United States
• Paducah Retinal Center — Paducah, Kentucky, United States
• Retinal Diagnostic Center — Campbell, California, United States

Full record on ClinicalTrials.gov

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