Back to resultsA 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)
Primary Purpose
Macular Edema, Retinal Vein Occlusion
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
KSI-301
Aflibercept
Sham Procedure
Sponsored by
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
Arm Type
Experimental
Active Comparator
Arm Label
KSI-301 (Arm A)
Aflibercept (Arm B)
Arm Description
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.
Outcomes
Primary Outcome Measures
Non-inferiority of KSI-301 to Aflibercept measured by changes in BCVA.
Demonstrate that KSI-301 5 mg administered every 8 weeks after 2 monthly doses is non-inferior to aflibercept 2 mg monthly with respect to mean change in best corrected visual acuity (BCVA).
Secondary Outcome Measures
Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA and CST.
Improvement in best corrected visual acuity (BCVA) and central subfield thickness (CST) between the two treatment arms.
Durability of KSI-301 5 mg compared to aflibercept 2 mg based on number of intravitreal injections during the study.
Mean number of intravitreal injections during the course of the study between the two treatment arms.
Safety and Tolerability of KSI-301 5 mg compared to aflibercept 2 mg based on the number of ocular and systemic adverse events.
Incidence of ocular and systemic adverse events up to Week 24, Week 52, and Week 76
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04592419
Brief Title
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)
Acronym
BEACON
Official Title
A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
January 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kodiak Sciences Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).
Detailed Description
This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch or central type).
The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.
This includes an optional open-label, two-arm, double-masked Extension Phase in which participants completing the primary BEACON study are eligible to participate. All participants who enroll into the Extension Phase will be treated with KSI-301 5 mg. The Extension Phase will have the final study assessment at Week 72 for efficacy endpoints and a final safety follow-up at Week 76.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Vein Occlusion
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.
Participants in the Extension Phase will be treated with KSI-301.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments.
Allocation
Randomized
Enrollment
568 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KSI-301 (Arm A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Aflibercept (Arm B)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
KSI-301
Intervention Description
Intravitreal Injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Intravitreal Injection
Intervention Type
Other
Intervention Name(s)
Sham Procedure
Intervention Description
The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
Primary Outcome Measure Information:
Title
Non-inferiority of KSI-301 to Aflibercept measured by changes in BCVA.
Description
Demonstrate that KSI-301 5 mg administered every 8 weeks after 2 monthly doses is non-inferior to aflibercept 2 mg monthly with respect to mean change in best corrected visual acuity (BCVA).
Time Frame
Day 1 to Week 24
Secondary Outcome Measure Information:
Title
Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA and CST.
Description
Improvement in best corrected visual acuity (BCVA) and central subfield thickness (CST) between the two treatment arms.
Time Frame
Day 1 to Week 44
Title
Durability of KSI-301 5 mg compared to aflibercept 2 mg based on number of intravitreal injections during the study.
Description
Mean number of intravitreal injections during the course of the study between the two treatment arms.
Time Frame
Week 1 to Week 44
Title
Safety and Tolerability of KSI-301 5 mg compared to aflibercept 2 mg based on the number of ocular and systemic adverse events.
Description
Incidence of ocular and systemic adverse events up to Week 24, Week 52, and Week 76
Time Frame
Day 1 to Week 76
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Janer, MD
Organizational Affiliation
Kodiak Sciences Inc
Official's Role
Study Director
Facility Information:
Facility Name
Northwest Arkansas Retina Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Vitreous Associates
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Eye Medical Center of Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
UCSD Jacobs Retina Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Northern California Retina Vitreous Associates
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Retina Consultants of San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Retina Consultants of Southern California
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Retinal Consultants Medical Group Inc
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
California Retina Consultants
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Colorado Retina Associates PC
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Facility Name
Conneticut Eye Consultants
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Retina Group of New England
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
Florida Eye Clinic
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Retina Group of Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Florida Eye Microsurgical Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
The Macula Center/ Blue Ocean Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Vitreo Retinal Associates
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Fort Lauderdale Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Southern Vitreoretinal Associates
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Retina Associates of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Center for Retina & Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Springfield Clinic LLP
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Talley Eye
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Retina Associates PA
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Vitreo Retinal Consultants and Surgeons
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Maine Eye Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Cumberland Valley Retina Consultants PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Vitreo Retinal Associates PC
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01603
Country
United States
Facility Name
Foundation for Vision Research
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Associated Retinal Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
78073
Country
United States
Facility Name
Vitreoretinal Surgery PA
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Retina Consultants of NV
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
The Retina Center of New Jersey
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07017
Country
United States
Facility Name
NJ Retina
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07605
Country
United States
Facility Name
Vitreo Retinal Consultants
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Facility Name
Retina-Vitreous Surgeons of Central NY
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Ocli Vision
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Retina Associates of Western NY
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Asheville Eye Associates
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Associates, P.A.
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Retina Associates of Cleveland
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Retina Associates of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Retina Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Retina Consultants, LLC
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Facility Name
Cascade Medical Research Institute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Retina Research of Beaufort
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
Retina Consultants of Carolina
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Pametto Retina Center
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Charles Retina Institute
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Southeastern Retina Associates PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Austin Research Center for Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Retina Consultants of Texas - (Katy)
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Texas Retina Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Austin Retina Associates (Round Rock)
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Texas - (Woodlands)
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Retina Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Retina Center Northwest
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Facility Name
Spokane Eye
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
OFTEX s.r.o.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Facility Name
Vseobecna Fakultni
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Lekarna BENU
City
Praha
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
CHRU Dijon Complexe Du Bocage
City
Dijon
State/Province
Côte-d'Or
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33076
Country
France
Facility Name
Hôpital de La Croix Rousse
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69317
Country
France
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Centre Paradis Monticelli
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hôpital Lariboisière - Service Pharmacie
City
Paris
ZIP/Postal Code
75 010
Country
France
Facility Name
Fondation Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
CHRU de Poitiers La Miletrie
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Dietrich Bonhoeffer Klinikum Neubrandenburg
City
Neubrandenburg
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
17036
Country
Germany
Facility Name
St. Elisabeth Krankenhaus
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50935
Country
Germany
Facility Name
Miriam Kannenbaeumer or Andrea Koschinski
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
Facility Name
MH EK Honvedkorhaz SzemEszeti Osztaly
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Bajcsy-Zsilinszky Korhaz es Rendelointezet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Budapest Retina Associates Kft
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Jahn Ferenc Dél-Pesti Kórház és Rendelointézet
City
Budapest
ZIP/Postal Code
1214
Country
Hungary
Facility Name
Bnai Zion
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam MC
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir MC
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan MC
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Assuta HaShalom
City
Tel Aviv
ZIP/Postal Code
6789140
Country
Israel
Facility Name
Shamir Medical Center Assaf Harofeh
City
Tzrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Ospedale Clinicizzato SS Annunziata
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Fondazione Policlinico Universitario A Gemelli
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale San Raffaele S.r.l. - PPDS
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Signes Ozolinas Doctor Praxis In Ophthalmology
City
Jelgava
ZIP/Postal Code
LV-3001
Country
Latvia
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Riga Eastern Clinical University Hospital Clinic Bikernieki
City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
Latvian American Eye Center
City
Riga
ZIP/Postal Code
LV-1009
Country
Latvia
Facility Name
Optimum Profesorskie Centrum Okulistyki
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-809
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-514
Country
Poland
Facility Name
Gabinet Okulistyczny Prof. Edward Wylegala
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-594
Country
Poland
Facility Name
Oftalmika Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Dr Nowosielska Okulistyka i Chirurgia Oka
City
Warszawa
ZIP/Postal Code
01-249
Country
Poland
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
City
Wrocław
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Emanuelli Research & Development Center LLC
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico
Facility Name
Fakultna nemocnica s poliklinikou F. D. Roosevelta
City
Banská Bystrica
ZIP/Postal Code
974 01
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Uvea Klinika, S.R.O.
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Nemocnica s poliklinikou Trebisov a.s.
City
Trebišov
ZIP/Postal Code
075 01
Country
Slovakia
Facility Name
Fakultna nemocnica Trencin
City
Trencín
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Hospital Universitario de Bellvitge
City
L'hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari General de Catalunya - Grupo Quironsalud
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital dos de Maig
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Instituto Clinico Quirurgico de Oftalmologia
City
Bilbao
ZIP/Postal Code
48010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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)
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