Study to Gather Information on Safety and Use of High Dose Aflibercept Injection Into the Eye in Patients With an Age Related Eye Disorder That Causes Blurred Vision or a Blind Spot Due to Abnormal Blood Vessels That Leak Fluid Into the Light Sensitive Lining Inside the Eye (PULSAR)
Neovascular Age-Related Macular Degeneration
About this trial
This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration focused on measuring nAMD
Eligibility Criteria
Inclusion Criteria:
- Active subfoveal CNV secondary to nAMD, including juxtafoveal lesions that affect the fovea as assessed in the study eye.
- Total area of CNV (including both classic and occult components) must comprise greater than 50% of the total lesion area in the study eye.
- BCVA ETDRS letter score of 78 to 24 (corresponding to a Snellen equivalent of approximately 20/32 to 20/320) in the study eye.
- Decrease in BCVA determined to be primarily the result of nAMD in the study eye.
- Presence of IRF and/or SRF affecting the central subfield of the study eye on OCT.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical studies.
- Other protocol-specified inclusion criteria.
Exclusion Criteria:
- Causes of CNV other than nAMD in the study eye.
- Scar, fibrosis, or atrophy involving the central subfield in the study eye.
- Presence of retinal pigment epithelial tears or rips involving the central subfield in the study eye.
- Uncontrolled glaucoma (defined as IOP >25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
- History of idiopathic or autoimmune uveitis in the study eye.
- Myopia of a spherical equivalent of at least 8 diopters in the study eye prior to any refractive or cataract surgery.
- History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any retinal vascular disease other than nAMD in either eye.
- Evidence of extraocular or periocular infection or inflammation (including infectious blepharitis, keratitis, scleritis, or conjunctivitis) in either eye at the time of screening/randomization.
- Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg).
- Any prior or concomitant ocular (in the study eye) or systemic treatment (with an investigational or approved, anti-VEGF or other agent) or surgery for nAMD, except dietary supplements or vitamins.
- Other protocol-specified exclusion criteria
Sites / Locations
- Arizona Retina and Vitreous Consultants - Research
- Retina Consultants of Orange County
- University of California San Diego
- Northern California Retina-Vitreous Associates
- California Eye Specialists
- Retina Consultants San Diego
- Retina Consultants of Southern California
- Kaiser Permanente Riverside Medical Center
- Retina Consultants of Southern Colorado, PC
- New England Retina Associates
- Rand Eye Institute
- Retina Group of Florida
- Vitreo-Retinal Associates
- Florida Retina Institute
- Florida Eye Associates
- Retina Macula Specialists of Miami
- Florida Retina Institute
- Retina Specialists
- Retina Vitreous Associates of Florida - Saint Petersburg
- Southern Vitreoretinal Associates
- Retina Consultants of Hawaii
- Retina Associates IL
- University Retina and Macula Associates
- Wolfe Eye Clinic, PC
- Retina Care Center
- Ophthalmic Consultants of Boston
- Vitreo Retinal Surgery PA
- Retina Consultants of Nevada
- Retina Center of New Jersey
- NJ Retina
- Eye Associates of New Mexico
- Long Island Vitreoretinal Consultants
- Long Island Vitreoretinal Consultants
- Ophthalmic Consultants of Long Island
- Ophthalmic Consultants of the Capital Region
- Wake Forest Baptist Health
- Midwest Retina - Main Office
- Retina Northwest, PC
- Retina Consultants, LLC
- Mid Atlantic Retina
- Erie Retinal Surgery, Inc.
- Eye Care Specialists
- Charleston Neuroscience Center
- Palmetto Retina Center, LLC
- Black Hills Regional Eye Institute
- Charles Retina Institute
- Vanderbilt University Medical School
- Austin Retina Associates
- Texas Retina Associates
- Medical Center Ophthalmology Associates
- Retinal Consultants of Texas - San Antonio
- Retina Consultants of Houston
- Retina Consultants of Texas - The Woodlands
- Fletcher Allen Health Care
- Spokane Eye Clinical Research
- West Virginia University
- University of Wisconsin - Madison
- Organizacion Medica de Investigacion (OMI)
- OFTALMOS, Instituto Oftalmologico de Alta Complejidad
- Eyeclinic Albury Wodonga
- Sydney Retina Clinic
- Westmead Hospital
- Hobart Eye Surgeons
- Marsden Eye Surgery Center
- Klinikum Klagenfurt am Wörthersee
- Kepler Universitätsklinikum Campus III
- Konventhospital Barmherzige Brüder Linz
- Medizinische Universität Graz
- Hanusch-Krankenhaus Wien
- SEHAT Pentagram
- Spec. Hosp. for Active Treatment for Eye Diseases Zrenie
- UMHAT Alexandrovska EAD
- Multiprofile Hospital for Active Treatment Sveta Sofia
- Specialized Hospital For Active Treatment of Eye Diseases Zora
- Sveta Petka Eye Hospital
- St.Joseph's Health Care-London
- Toronto Retina Institute
- Institut de l'Oeil des Laurentides
- The Second Hospital of Anhui medical university
- The 1st Affiliated Hospital Fujian Medical University
- Guangzhou Aier Eye Hospital
- Shijiazhuang General Hospital
- Hebei Eye Hospital
- Henan Provincial Ophthalmology Hospital (Henan Eye Institute
- Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.
- Union Hospt Tongji Medical Colleg. Huazhong univ. Scien&Tech
- The First People's Hospital of Xuzhou
- Jiangxi Provincial People's Hospital
- The First Affiliated Hospital of NanChang University
- Eye Center of the second Bethune Hospital, jinlin University
- Tonghua Central Hospital
- Shenyang He Eye Hospital
- The People's Hospital of Ningxia Hui Autonomous Region
- The First Affiliated Hospital of Xi'an Jiaotong University
- Aier Eye Hospital (Chengdu)
- The First Affiliated Hospital of Xinjiang Medical University
- The 1st Affiliated Hospital of Zhejiang University
- ZheJiang Provincial People's Hospital
- The Affiliated Eye Hospital of Wenzhou Medical College
- Beijing Tongren Hospital, Capital Medical University (East)
- Beijing Aier Intech Eye Hospital Co. LTD - Ophthalmology
- Peking University People's Hospital
- Beijing Hospital
- Chongqing Aier Ophthalmology Hospital
- Shanghai Tongji Hospital of Tongji University
- Shanghai General Hospital
- Tianjin Medical University General Hospital
- Tianjin Medical University Eye Hospital
- TianJin eye hospital
- Fakultni Nemocnice Hradec Kralove
- Fakultni nemocnice Ostrava
- Fakultni nemocnice Plzen - Lochotin
- Charles University in Prague
- Fakultni nemocnice Kralovske Vinohrady
- Lexum a.s., Evropska ocni klinika
- AXON Clinical s.r.o.
- East Tallinn Central Hospital
- Tartu University Hospital
- Centre d'Ophtalmologie - Paradis-Monticelli
- Hôpital Lariboisière - Paris
- Centre ophtalmologique Saint-Exupéry
- LTD "Clinic LJ"
- JSC "Evex Hospitals'
- LTD "Innova"
- LTD "Chichua Medical Center MZERA"
- Budapest Retina Associates
- Szent-Gyorgyi Albert Orvostudomanyi Egyetem
- Rambam Health Corporation
- Lady Davis Carmel Medical Center
- Hadassah Hebrew University Hospital Ein Kerem
- Meir Medical Center
- Chaim Sheba Medical Center
- Kaplan Medical Center
- Assuta Medical Centers - HaShalom
- Fondazione PTV Policlinico Tor Vergata
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- IRCCS Fondazione G.B. Bietti Studio e Ricerca in Otalmologia
- Ospedale San Raffaele s.r.l.
- ASST Fatebenefratelli Sacco
- A.O.U. di Cagliari
- A.O. di Perugia
- Daiyukai Daiichi Hospital
- Aichi Medical University Hospital
- Nagoya University Hospital
- Nagoya City University Hospital
- Kokura Memorial Hospital
- Kurume University Hospital
- Southern Tohoku Eye Clinic
- Gunma University Hospital
- Sapporo City General Hospital
- KKR Sapporo Medical Center
- Hyogo Prefectural Amagasaki General Medical Center
- Kobe University Hospital
- Kozawa Eye Hospital and Diabetes Center
- Kanazawa Medical University Hospital
- Kanazawa University Hospital
- Kagawa University Hospital
- Medical corporation Eiwakai Dannoue Ophthalmology clinic
- St. Marianna University Hospital
- Otakeganka Tsukimino Clinic
- Mie University Hospital
- Shinshu University Hospital
- Nara Medical University Hospital
- Oita University Hospital
- Kurashiki Medical Center
- University of the Ryukyus Hospital
- Kansai Medical University Hospital
- Kansai Medical University Medical Center
- Kindai University Hospital
- The University of Tokyo Hospital
- St.Luke's International Hospital
- Nishikasai Inouye Eye Hospital
- Tokyo Medical University Hachioji Medical Center
- Tokiwadai Muranaka Eye Clinic
- National Hospital Organization Tokyo Medical Center
- Keio University Hospital
- Tokyo Women's Medical University Hospital
- Yamaguchi University Hospital
- University of Yamanashi Hospital
- Akita University Hospital
- Hayashi Eye Hospital
- Fukushima Medical University Hospital
- Hiroshima University Hospital
- University of Miyazaki Hospital
- Japanese Red Cross Nagasaki Genbaku Hospital
- Okayama University Hospital
- Japanese Red Cross Saitama Hospital
- Tokushima University Hospital
- Japanese Red Cross Wakayama Medical center
- Yamagata University Hospital
- Seoul National University Bundang Hospital
- Pusan National University Hospital
- Inje University Haeundae Paik Hospital
- Seoul National University Hospital
- Asan Medical Center
- Samsung Medical Center
- Retina Center Nune Eye Hospital
- Department of Ophthalmology
- Riga East Clinical University Hospital "Gailezers"
- Latvian American Eye Center
- Hospital of LT University of Health Sciences Kaunas Clinics
- PI Klaipedos University Hospital
- Vilnius University Hospital Santaros Klinikos
- ALM Oftalmolaser - Oftalmologia Medica e Cirurgica
- AIBILI
- Espaco Medico de Coimbra
- Centro Hospitalar Universitario do Porto
- Centro Hospitalar Vila Nova de Gaia/Espinho | Unit 1 - Clinical Research Office
- Scientific Research Institution of Ophthalmic Diseases
- FBSI IRTC Eye Microsurgery n.a. acad. S.N. Fyodorov
- Clinical Center of Serbia
- Clinical hospital center Zvezdara
- Klinicki centar Vojvodine
- National University Hospital
- Singapore National Eye Centre
- Fakultna nemocnica Nitra
- Nemocnica s Poliklinikou Trebisov, Svet zdravia a.s.
- Fakultna nemocnica Trencin
- Fakultna nemocnica s poliklinikou Zilina
- Instituto Oftalmológico Francisco Gomez Ulla
- Hospital Clínic i Provincial de Barcelona
- Hospital de la Santa Creu i Sant Pau | Gynecology Department
- Hospital Reina Sofía
- Hospital General Universitario de Valencia
- Hospital Universitari i Politècnic La Fe
- Hospital Miguel Servet
- RétinElysée
- Berner Augenklinik am Lindenhofspital
- Stadtspital Triemli
- Shin Kong Wu Ho-Su Memorial Hospital
- Taipei Veterans General Hospital
- Chang Gung Memorial Hospital at Linkou
- Private enterprise private production company " Acinus"
- Centralna Polyclinica MVS Ukraiiny
- Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Aflibercept 2q8
Aflibercept HDq12
Aflibercept HDq16
In the double-masked study part (Years 1 and 2), Aflibercept 2 mg administered every 8 weeks after a loading phase. (Active Comparator) In Year 3, high dose aflibercept administered according to individual patient response. (Experimental)
Aflibercept high dose (HD) administered every 12 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.
Aflibercept high dose administered every 16 weeks after an initiation phase. Treatment intervals adjusted according to individual patient response.