DRCR.Net Aflibercept vs. Bevacizumab + Deferred Aflibercept for the Treatment of CI-DME
- Conditions
- Diabetic Macular Edema
- Interventions
- Drug: intravitreous aflibercept
- Registration Number
- NCT03321513
- Lead Sponsor
- Jaeb Center for Health Research
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 270
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bevacizumab + Deferred Aflibercept Group intravitreous aflibercept 1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria Aflibercept Group intravitreous aflibercept 2.0 mg intravitreous aflibercept Bevacizumab + Deferred Aflibercept Group Bevacizumab + Deferred Aflibercept Group 1.25 mg intravitreous bevacizumab + deferred intravitreous 2.0 mg aflibercept if eye meets switch criteria
- Primary Outcome Measures
Name Time Method Mean Change in Visual Acuity 2 years Area under the curve mean change in the electronic early treatment diabetic retinopathy study visual acuity. Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, \<20/800), with higher scores indicating better vision. The data presented are the best-corrected visual acuity in the study eye after protocol-defined refraction. The primary outcome was the time-averaged change in the visual-acuity letter score over a period of 104 weeks. The score was derived by calculating the area under the curve (AUC) over the 104-week period for the change in visual acuity from baseline and dividing by the length of follow-up.
- Secondary Outcome Measures
Name Time Method Optical Coherence Tomography Central Subfield Thickness Change From Baseline 2 years Measurements made on the Cirrus device were converted to equivalent scores as would be assessed on the Spectralis device with the use of the following formula: Spectralis score = 40.78 + 0.95 × Cirrus score.
Decrease in E-ETDRS Visual Acuity Letter Score 2 years Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, \<20/800), with higher scores indicating better vision.
Visual Acuity 2 years Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, \<20/800), with higher scores indicating better vision.
Number of Eyes in the Bevacizumab-first Group Meeting the Switching Criteria Baseline to 104 weeks Increase in E-ETDRS Visual Acuity Letter Score 2 years Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, \<20/800), with higher scores indicating better vision.
Optical Coherence Tomography Central Subfield Thickness Below the Sex-specific Threshold for Central-involved Diabetic Macular Edema 2 years Optical coherence tomography (OCT) central subfield thickness equivalents for measurements obtained on Spectral domain OCT machines were 320 μm for men and 305 μm for women on the Spectralis device (Heidelberg) and were 305 μm and 290 μm, respectively on the Cirrus OCT measurement device (Zeiss).
Change in Visual Acuity From Baseline 2 years Visual acuity was measured with the Electronic Early Treatment Diabetic Retinopathy Study visual-acuity test on a scale from 100 letters (Snellen equivalent, 20/10) to 0 letters (Snellen equivalent, \<20/800), with higher scores indicating better vision.
Number of Visits 2 years Number of Injections 2 years All study injections were counted, including aflibercept injections received among eyes in the bevacizumab first group.
Trial Locations
- Locations (54)
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
🇺🇸West Monroe, Louisiana, United States
Retinavitreous Associates, dba; Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Florida Retina Consultants
🇺🇸Lakeland, Florida, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
Retina Associates of Sarasota
🇺🇸Sarasota, Florida, United States
Retina Specialists of Tampa
🇺🇸Wesley Chapel, Florida, United States
Retina Macula Specialists of Miami
🇺🇸Miami, Florida, United States
Raj K. Maturi, M.D., P.C.
🇺🇸Indianapolis, Indiana, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Baylor Eye Physicians and Surgeons
🇺🇸Houston, Texas, United States
Retina Consultants of Houston, PA
🇺🇸Houston, Texas, United States
Retina Associates, P.A.
🇺🇸Shawnee Mission, Kansas, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Retinal Consultants of San Antonio
🇺🇸San Antonio, Texas, United States
Retina Northwest, PC
🇺🇸Portland, Oregon, United States
Retina Associates of Florida, LLC
🇺🇸Tampa, Florida, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
East Bay Retina Consultants, Inc
🇺🇸Oakland, California, United States
Macula & Retina Institute
🇺🇸Glendale, California, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
Loma Linda University Health Care, Department of Ophthalmology
🇺🇸Loma Linda, California, United States
Florida Retina Institute-Jacksonville
🇺🇸Jacksonville, Florida, United States
Sarasota Retina Institute
🇺🇸Sarasota, Florida, United States
Thomas Eye Group
🇺🇸Sandy Springs, Georgia, United States
Southeast Retina Center, P.C.
🇺🇸Augusta, Georgia, United States
Illinois Retina Associates, S.C.
🇺🇸Oak Park, Illinois, United States
Springfield Clinic, LLP
🇺🇸Springfield, Illinois, United States
Mid-America Retina Consultants, P.A.
🇺🇸Overland Park, Kansas, United States
John-Kenyon American Eye Institute
🇺🇸New Albany, Indiana, United States
Paducah Retinal Center
🇺🇸Paducah, Kentucky, United States
Mid Atlantic Retina Specialists
🇺🇸Hagerstown, Maryland, United States
Valley Eye Physicians and Surgeons
🇺🇸Ayer, Massachusetts, United States
Retina Specialists of Michigan
🇺🇸Grand Rapids, Michigan, United States
Vitreo-Retinal Associates
🇺🇸Grand Rapids, Michigan, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, United States
MaculaCare
🇺🇸New York, New York, United States
Western Carolina Clinical Research, LLC
🇺🇸Asheville, North Carolina, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Charlotte Eye, Ear, Nose and Throat Assoc., PA
🇺🇸Charlotte, North Carolina, United States
Cascade Medical Research Institute, LLC
🇺🇸Springfield, Oregon, United States
Retina Vitreous Consultants
🇺🇸Monroeville, Pennsylvania, United States
Southeastern Retina Associates, P.C.
🇺🇸Knoxville, Tennessee, United States
Austin Retina Associates
🇺🇸Austin, Texas, United States
Retina Center of Texas
🇺🇸Grapevine, Texas, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Texas Retina Associates
🇺🇸Lubbock, Texas, United States
Spokane Eye Clinic
🇺🇸Spokane, Washington, United States
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Central Florida Retina
🇺🇸Orlando, Florida, United States
Florida Retina Institute
🇺🇸Orlando, Florida, United States