Phase 3Completed
DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME (DRCR AC)
Randomized Trial of Intravitreous Aflibercept Versus Intravitreous Bevacizumab + Deferred Aflibercept for Treatment of Central-Involved Diabetic Macular Edema
- Sponsor
- Jaeb Center for Health Research (Academic or other)
- Enrolment
- 270 enrolled
- Conditions
- Diabetic Macular Edema
- Interventions
- intravitreous aflibercept; Bevacizumab + Deferred Aflibercept Group
- Ages
- adults, older adults
- Registry
- NCT03321513
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Mean Change in Visual Acuity
History
Last registry update
Results first posted
Primary completion
Started
Registered