A Study to Learn How Well a Higher Amount of Aflibercept Given as an Injection Into the Eye Works and How Safe it is in People With Reduced Vision Due to Swelling in the Macula, Central Part of the Retina Caused by a Blocked Vein in the Retina (Macula Edema Secondary to Retinal Vein Occlusion)
研究单位：[1]Bayer[2]Regeneron Pharmaceuticals[3]Retina Consultants of Orange County,Fullerton,California,United States,92835[4]Mountain View | Ophthalmology,Loma Linda,California,United States,92354[5]South Coast Retina Center,Long Beach,California,United States,90807[6]Northern California Retina-Vitreous Associates,Mountain View,California,United States,94040[7]Southern California Desert Retina Consultants,Palm Springs,California,United States,92262[8]California Eye Specialists,Pasadena,California,United States,91107[9]Southern California Permanente Medical Group,Riverside,California,United States,92505[10]Stanford University,Stanford,California,United States,94305[11]Retina Consultants of Southern Colorado, PC,Colorado Springs,Colorado,United States,80909[12]New England Retina Associates,New London,Connecticut,United States,06320[13]Rand Eye Institute,Deerfield Beach,Florida,United States,33064[14]National Ophthalmic Research Institute,Fort Myers,Florida,United States,33912[15]Eye Institute of West Florida,Largo,Florida,United States,33770[16]Florida Eye Associates,Melbourne,Florida,United States,32901[17]Florida Retina Institute,Orlando,Florida,United States,32806[18]Retina Specialists,Pensacola,Florida,United States,32503[19]Fort Lauderdale Eye Institute,Plantation,Florida,United States,33324[20]Retina Vitreous Associates of Florida - Saint Petersburg,Saint Petersburg,Florida,United States,33711-1141[21]East Florida Eye Institute,Stuart,Florida,United States,34994[22]University of South Florida,Tampa,Florida,United States,33612[23]Center for Retina and Macular Disease,Winter Haven,Florida,United States,33880[24]Marietta Eye Clinic,Marietta,Georgia,United States,30060[25]Retina Associates IL,Elmhurst,Illinois,United States,60126[26]University Retina and Macula Associates,Oak Forest,Illinois,United States,60452[27]Retina Associates, LLC,Lenexa,Kansas,United States,66215[28]Retina Care Center,Baltimore,Maryland,United States,21209[29]Cumberland Valley Retina Consultants, PC,Hagerstown,Maryland,United States,21740[30]Mid Atlantic Retina Specialists,Hagerstown,Maryland,United States,21740[31]Vitreo-Retinal Associates, PC,Grand Rapids,Michigan,United States,49525[32]Retina Consultants of Minnesota,Saint Louis Park,Minnesota,United States,55416[33]Retina Consultants of Nevada,Las Vegas,Nevada,United States,89144[34]Sierra Eye Associates,Reno,Nevada,United States,89502[35]Retina Center of New Jersey,Bloomfield,New Jersey,United States,07003[36]NJ Retina,New Brunswick,New Jersey,United States,08901[37]NJ Retina | Teaneck,Teaneck,New Jersey,United States,07666[38]Eye Associates of New Mexico,Albuquerque,New Mexico,United States,87106[39]Long Island Vitreoretinal Consultants,Great Neck,New York,United States,11021[40]Long Island Vitreoretinal Consultants,Hauppauge,New York,United States,11788[41]Ophthalmic Consultants of Long Island,Lynbrook,New York,United States,11563[42]Retina Associates of Western New York,Rochester,New York,United States,14620[43]Ophthalmic Consultants of the Capital Region,Troy,New York,United States,12180[44]University of NC at Chapel Hill (UNC) Ophthalmology,Chapel Hill,North Carolina,United States,27599[45]Wake Forest Baptist Health,Winston-Salem,North Carolina,United States,27157[46]Cincinnati Eye Institute,Cincinnati,Ohio,United States,45242[47]Midwest Retina - Main Office,Dublin,Ohio,United States,43016[48]Retina Consultants, LLC,Salem,Oregon,United States,97302[49]University of Pennsylvania,Philadelphia,Pennsylvania,United States,19104[50]Mid Atlantic Retina,Philadelphia,Pennsylvania,United States,19107[51]Retina Consultants of Charleston,Charleston,South Carolina,United States,29414[52]Palmetto Retina Center, LLC - Florence,Florence,South Carolina,United States,29501[53]Palmetto Retina Center, LLC,West Columbia,South Carolina,United States,29169[54]Charles Retina Institute,Memphis,Tennessee,United States,38119[55]Austin Retina Associates,Austin,Texas,United States,78705[56]Retinal Consultants of
研究目的：
Researchers are looking for a better way to treat people who have macular edema secondary to retinal vein occlusion (RVO). In people with RVO, a blood vessel that carries blood away from the retina (vein) becomes blocked. The retina is the very back part of the eye. The blocked vein causes fluid and blood to leak into the retina and thereby causes a swelling of the macula (the center of the retina responsible for fine vision). This swelling is called macular edema. When a vein in the retina is blocked, the levels of a protein called vascular endothelial growth factor (VEGF) rises. VEGF helps the growth of new blood vessels. This can lead to macular edema and may cause the vision to become blurry. The study treatment intravitreal (IVT) aflibercept is given as an injection into the eye. It works by blocking VEGF and this can help repair vision problems related to RVO. IVT aflibercept is already available and is prescribed by doctors as the standard of care treatment for macula edema secondary to RVO. Standard of care is a treatment that medical experts consider most appropriate for a disease. Standard of care is given every 4 weeks in people with macula edema secondary to RVO. While repeated injections of aflibercept may prevent worsening of vision, it may place a burden on the patient. However, a higher amount (8 mg) compared to the standard of care (2 mg) of IVT aflibercept is being tested in studies. This higher amount could be given less often. The amount of IVT aflibercept given is measured in milligrams, also known as mg. The main purpose of this study is to learn how well a higher amount of the study treatment aflibercept works in people with macular edema secondary to RVO. To answer this, researchers will measure changes in vision called best corrected visual acuity (BCVA) in the study participants between study start and after 36 weeks of treatment. Changes will then be compared between those participants who received the higher amount of IVT aflibercept and those that received standard of care. To learn how safe the study treatment is in the participants, the researchers will count the number of participants from study start and up to 64 weeks later that have: - adverse events - serious adverse events "Adverse events" are any medical problems that the participants have during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think they might be related to the study treatments. An adverse event is considered "serious" when it leads to death, puts the participants' lives at risk, requires hospitalization, causes disability, causes a baby being born with medical problems or is otherwise medically important. Dependent on the treatment group, the participants will either receive the higher amount of aflibercept or standard of care as an intravitreal injection for up to 60 weeks. The study will consist of a test (screening) phase, a treatment phase and an end of study phase. Each participant will be in the study for up to 64 weeks. One visit to the study site is planned during the screening phase, followed by visits approximately every 4 weeks (16 in total) during treatment and one visit at the end of the study. During the study, the study doctors and their team will: - check patients' eye health using various eye examination techniques - measure patients' eye vision (BCVA) - take blood and urine samples - do physical examinations - check vital signs - examine heart health using electrocardiogram (ECG) - do pregnancy tests in women of childbearing age In addition, particip
