A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (BEACON)
Macular Edema, Retinal Vein Occlusion
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring RVO, Kodiak, KSI-301, Vascular endothelial growth factor, Anti-VEGF, VEGF, Antibody biopolymer conjugate, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, low, Aflibercept, Eylea
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent prior to participation in the study.
- Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
- BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
- CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
- Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Macular edema in the Study Eye for reasons other than RVO
- Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
- Uncontrolled glaucoma in the Study Eye.
- Active retinal disease other than the condition under investigation in the Study Eye.
- Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
- Active or suspected ocular or periocular infection or inflammation
- Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
- Women who are pregnant or lactating or intending to become pregnant during the study.
- Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
- Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
- History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
- Northwest Arkansas Retina Associates
- Retinal Research Institute, LLC
- Retina Vitreous Associates
- Eye Medical Center of Fresno
- Retina Consultants of Orange County
- UCSD Jacobs Retina Center
- Northern California Retina Vitreous Associates
- Retina Consultants of San Diego
- Retina Consultants of Southern California
- Retinal Consultants Medical Group Inc
- Orange County Retina Medical Group
- California Retina Consultants
- Colorado Retina Associates PC
- Conneticut Eye Consultants
- Retina Group of New England
- Florida Eye Clinic
- Retina Group of Florida
- Florida Eye Microsurgical Institute
- The Macula Center/ Blue Ocean Clinical Research
- Rand Eye Institute
- National Ophthalmic Research Institute
- Vitreo Retinal Associates
- Florida Eye Associates
- Florida Retina Institute
- Retina Specialty Institute
- Fort Lauderdale Eye Institute
- Southern Vitreoretinal Associates
- Retina Associates of Florida
- Center for Retina & Macular Disease
- Southeast Retina Center
- Springfield Clinic LLP
- Talley Eye
- Wolfe Eye Clinic
- Retina Associates PA
- Vitreo Retinal Consultants and Surgeons
- Retina Associates of Kentucky
- Maine Eye Center
- Retina Group of Washington
- Cumberland Valley Retina Consultants PC
- Ophthalmic Consultants of Boston
- Vitreo Retinal Associates PC
- Foundation for Vision Research
- Associated Retinal Consultants PC
- Vitreoretinal Surgery PA
- Retina Consultants of NV
- Sierra Eye Associates
- The Retina Center of New Jersey
- NJ Retina
- Vitreo Retinal Consultants
- Retina-Vitreous Surgeons of Central NY
- Ocli Vision
- Retina Associates of Western NY
- Asheville Eye Associates
- Charlotte Eye Ear Nose & Throat Associates, P.A.
- Retina Associates of Cleveland
- Retina Associates of Cleveland
- Retina Northwest
- Retina Consultants, LLC
- Cascade Medical Research Institute
- Retina Research of Beaufort
- Retina Consultants of Carolina
- Charleston Neuroscience Institute
- Pametto Retina Center
- Black Hills Regional Eye Institute
- Charles Retina Institute
- Southeastern Retina Associates PC
- Tennessee Retina PC
- Retina Research Institute of Texas
- Austin Research Center for Retina
- Austin Retina Associates
- Retina Research Center
- Retina Consultants of Texas
- Retina Consultants of Texas - (Katy)
- Texas Retina Associates
- Austin Retina Associates (Round Rock)
- Medical Center Ophthalmology Associates
- Retina Consultants of Texas - (Woodlands)
- Strategic Clinical Research Group, LLC
- Retina Institute of Virginia
- Retina Center Northwest
- Spokane Eye
- OFTEX s.r.o.
- Vseobecna Fakultni
- Lekarna BENU
- CHRU Dijon Complexe Du Bocage
- Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
- Hôpital de La Croix Rousse
- Centre Hospitalier Intercommunal de Créteil
- Centre Paradis Monticelli
- Hôpital Lariboisière - Service Pharmacie
- Fondation Rothschild
- CHRU de Poitiers La Miletrie
- Universitätsklinikum Regensburg
- Dietrich Bonhoeffer Klinikum Neubrandenburg
- St. Elisabeth Krankenhaus
- Miriam Kannenbaeumer or Andrea Koschinski
- MH EK Honvedkorhaz SzemEszeti Osztaly
- Semmelweis Egyetem
- Bajcsy-Zsilinszky Korhaz es Rendelointezet
- Budapest Retina Associates Kft
- Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
- Bnai Zion
- Rambam MC
- Hadassah University Hospital
- Meir MC
- Rabin Medical Center
- Kaplan MC
- Tel Aviv Sourasky Medical Center
- Assuta HaShalom
- Shamir Medical Center Assaf Harofeh
- Ospedale Clinicizzato SS Annunziata
- Fondazione PTV Policlinico Tor Vergata
- Fondazione Policlinico Universitario A Gemelli
- Ospedale San Raffaele S.r.l. - PPDS
- Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
- Signes Ozolinas Doctor Praxis In Ophthalmology
- Pauls Stradins Clinical University Hospital
- Riga Eastern Clinical University Hospital Clinic Bikernieki
- Latvian American Eye Center
- Optimum Profesorskie Centrum Okulistyki
- Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
- Gabinet Okulistyczny Prof. Edward Wylegala
- Oftalmika Sp. z o.o.
- Dr Nowosielska Okulistyka i Chirurgia Oka
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
- Emanuelli Research & Development Center LLC
- Fakultna nemocnica s poliklinikou F. D. Roosevelta
- Univerzitna nemocnica Bratislava
- Uvea Klinika, S.R.O.
- Nemocnica s poliklinikou Trebisov a.s.
- Fakultna nemocnica Trencin
- Hospital Universitario de Bellvitge
- Hospital Universitari General de Catalunya - Grupo Quironsalud
- Hospital Universitario Puerta de Hierro - Majadahonda
- Hospital dos de Maig
- Hospital Clinic de Barcelona
- Instituto Clinico Quirurgico de Oftalmologia
- Hospital Universitari i Politecnic La Fe de Valencia
- Hospital Universitario Rio Hortega
- Hospital Clinico Universitario Lozano Blesa
- Hospital Universitario Miguel Servet
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
KSI-301 (Arm A)
Aflibercept (Arm B)
Intravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44. In the Extension Phase, participants randomized to KSI-301 (5 mg) in the Primary Study will continue to receive KSI-301 (5 mg) based on protocol-defined disease activity criteria.
Intravitreal injection of aflibercept (2 mg) once every 4 through Week 20 followed by an individualized dosing regimen of Intravitreal injection of Aflibercept (2 mg) once every 4 weeks from Week 24 to Week 44. In the Extension Phase, participants randomized to aflibercept in the Primary Study will cross over to treatment with KSI-301 (5 mg). They will receive their first dose of KSI-301 (5 mg) at Week 48 and will receive additional treatment with KSI-301 (5 mg) based on protocol-defined disease activity criteria.