270
Participants
Start Date
December 7, 2017
Primary Completion Date
December 22, 2021
Study Completion Date
December 22, 2021
intravitreous aflibercept
"Intravitreous aflibercept injection is made by Regeneron Pharmaceuticals, Inc. and is approved by the FDA for the treatment of neovascular age-related macular degeneration, macular edema due to central retinal vein occlusion, macular edema due to branch retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in eyes with diabetic macular edema.~Study eyes assigned to receive aflibercept will receive a dose of 2.0 mg in 0.05 cc. Aflibercept will be obtained commercially by the clinical site. The physical, chemical, and pharmaceutical properties and formulation of aflibercept are provided in the Package Insert.~Intravitreous Injection Technique The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used.~The injection will be performed using sterile technique"
Bevacizumab + Deferred Aflibercept Group
"Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma.~Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc.~Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used.~The injection will be performed using a sterile technique."
MaculaCare, New York
Retina Associates of Western New York, Rochester
Retina Vitreous Consultants, Monroeville
Mid Atlantic Retina Specialists, Hagerstown
Charlotte Eye, Ear, Nose and Throat Assoc., PA, Charlotte
Western Carolina Clinical Research, LLC, Asheville
Thomas Eye Group, Sandy Springs
Southeast Retina Center, P.C., Augusta
Florida Retina Institute-Jacksonville, Jacksonville
Central Florida Retina, Orlando
Florida Retina Institute, Orlando
Retina Macula Specialists of Miami, Miami
Fort Lauderdale Eye Institute, Plantation
Retina Specialists of Tampa, Wesley Chapel
Retina Associates of Florida, LLC, Tampa
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas, Pinellas Park
Florida Retina Consultants, Lakeland
National Ophthalmic Research Institute, Fort Myers
Retina Associates of Sarasota, Sarasota
Sarasota Retina Institute, Sarasota
Southeastern Retina Associates, P.C., Knoxville
Paducah Retinal Center, Paducah
University Hospitals Cleveland Medical Center, Cleveland
Raj K. Maturi, M.D., P.C., Indianapolis
John-Kenyon American Eye Institute, New Albany
Retina Specialists of Michigan, Grand Rapids
Vitreo-Retinal Associates, Grand Rapids
Medical College of Wisconsin, Milwaukee
Illinois Retina Associates, S.C., Oak Park
Springfield Clinic, LLP, Springfield
The Retina Institute, St Louis
Retina Associates, P.A., Shawnee Mission
Mid-America Retina Consultants, P.A., Overland Park
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center, West Monroe
Dean A. McGee Eye Institute, Oklahoma City
Retina Center of Texas, Grapevine
Baylor Eye Physicians and Surgeons, Houston
Retina Consultants of Houston, PA, Houston
Retinal Consultants of San Antonio, San Antonio
Valley Retina Institute, McAllen
Austin Retina Associates, Austin
Retina Research Center, Austin
Texas Retina Associates, Lubbock
Eye Associates of New Mexico, Albuquerque
Macula & Retina Institute, Glendale
Loma Linda University Health Care, Department of Ophthalmology, Loma Linda
Retinal Diagnostic Center, Campbell
Retina Northwest, PC, Portland
Cascade Medical Research Institute, LLC, Springfield
Spokane Eye Clinic, Spokane
East Bay Retina Consultants, Inc, Oakland
Valley Eye Physicians and Surgeons, Ayer
Joslin Diabetes Center, Boston
Retinavitreous Associates, dba; Mid Atlantic Retina, Philadelphia
Lead Sponsor
Jaeb Center for Health Research
OTHER