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A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (DAZZLE)

Primary Purpose

Wet Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KSI-301
Aflibercept
Sham Procedure
Sponsored by
Kodiak Sciences Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring AMD, Wet AMD, choroidal neovascularization secondary to age-related macular degeneration, KSI-301, Aflibercept, Vascular endothelial growth factor, VEGF, Anti-VEGF, Antibody biopolymer conjugate, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, low, Kodiak

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent prior to participation in the study.
  • Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
  • BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
  • Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

  • CNV secondary to other causes in the Study Eye.
  • Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
  • Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
  • Active ocular or periocular infection or inflammation.
  • Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
  • Uncontrolled glaucoma in the Study Eye.
  • Women who are pregnant or lactating or intending to become pregnant during the study.
  • Stroke or myocardial infarction in the 6-month period prior to Day 1.
  • Uncontrolled blood pressure defined as a systolic value > 180 mmHg or diastolic value ≥100 mmHg while at rest.
  • 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

  • Retinal Research Institute, LLC
  • Northwest Arkansas Retina Associates
  • California Retina Consultants
  • Retina Vitreous Associates
  • Eye Medical Center of Fresno
  • Retina Consultants of Orange County
  • UCSD Jacobs Retina Center
  • Retina Associates of Orange County
  • Northern California Retina Vitreous Associates
  • Retina Consultants of San Diego
  • Retinal Consultants Medical Group Inc
  • Orange County Retina Medical Group
  • California Retina Consultants
  • Colorado Retina Associates PC
  • Florida Eye Microsurgical Institute
  • Rand Eye Institute
  • Retina Health Center
  • National Ophthalmic Research Institute
  • Florida Eye Associates
  • Retina Specialty Institute
  • Retina Vitreous Associates of Florida
  • Retina Associates of Florida
  • Southeast Retina Center
  • Wolfe Eye Clinic
  • Retina Associates PA
  • Vitreo Retinal Consultants and Surgeons
  • Retina Associates of Kentucky
  • Cumberland Valley Retina Consultants PC
  • New England Retina Consultants
  • Vitreo Retinal Associates PC
  • Foundation for Vision Research
  • Associated Retinal Consultants PC
  • Vitreoretinal Surgery PA
  • Springfield Clinic LLP
  • Sierra Eye Associates
  • The Retina Center of New Jersey
  • NJ Retina
  • Retina Associates of Cleveland
  • Retina Associates of Cleveland
  • Cleveland Clinic Foundation, Cole Eye Institute
  • Retina and Vitreous Center of Southern Oregon PC
  • Cascade Medical Research Institute
  • Retina Northwest
  • Wills Eye Hospital
  • Palmetto Retina Center
  • Charleston Neuroscience Institute
  • Black Hills Regional Eye Institute
  • Southeastern Retina Associates PC
  • Tennessee Retina PC
  • Retina Research Institute of Texas
  • Austin Clinical Research, LLC
  • Austin Retina Associates
  • 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
  • Axon Clinical, s.r.o.
  • Universitätsklinikum Bonn
  • Medizinische Hochschule Hannover
  • Uniklinik Köln
  • Universitatsklinikum Leipzig
  • Pauls Stradins Clinical University Hospital
  • Riga Eastern Clinical University Hospital Clinic Bikernieki
  • Oftalmika Sp. z o.o.
  • Gabinet Okulistyczny prof. E. Wylegala
  • Retina Okulistyka Sp. z o.o. Sp. km.
  • Univerzitna nemocnica Bratislava
  • Nemocnica Trebisov - SVET ZDRAVIA - PPDS
  • Fakultna nemocnica Trencin
  • Fakultna nemocnica s poliklinikou Zilina
  • Institut de La Macula i La Retina
  • Hospital dos de Maig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KSI-301 5 mg

Aflibercept 2 mg

Arm Description

Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol. Drug: Sham Procedure. 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.

Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. Drug: Sham Procedure. 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.

Outcomes

Primary Outcome Measures

Mean change in Best Corrected Visual Acuity (BCVA) from Day 1.
BCVA is measured using ETDRS visual acuity charts.

Secondary Outcome Measures

Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301.
Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from Day 1.
Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from Day 1.
Proportion of subjects with BCVA Snellen equivalent of 20/40 or better.
Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse.
Mean change in OCT central subfield retinal thickness (CST) from Day 1.
Mean change in OCT intraretinal fluid volume from Day 1.
Mean change in OCT subretinal fluid volume from Day 1.
Proportion of subjects without intraretinal fluid on OCT.
Proportion of subjects without subretinal fluid on OCT.
Mean change in CNV total lesion area on FA from baseline.
Mean chance in area of leakage on FA from baseline.

Full Information

First Posted
August 6, 2019
Last Updated
June 2, 2022
Sponsor
Kodiak Sciences Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04049266
Brief Title
A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.
Acronym
DAZZLE
Official Title
A Phase 2b/3, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects With Neovascular (Wet) Age-related Macular Degeneration.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Primary Endpoint Not Met
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
November 17, 2021 (Actual)
Study Completion Date
April 26, 2022 (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 study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).
Detailed Description
This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg. At Week 52 patients on the aflibercept treatment arm will be re-randomized 1:1 into KSI-301 5 mg and aflibercept 2 mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wet Macular Degeneration
Keywords
AMD, Wet AMD, choroidal neovascularization secondary to age-related macular degeneration, KSI-301, Aflibercept, Vascular endothelial growth factor, VEGF, Anti-VEGF, Antibody biopolymer conjugate, Macular Degeneration, Wet Macular Degeneration, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, low, Kodiak

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
A masked evaluating investigator will be responsible for subject care except the injections and the safety assessment following the injections. An unmasked treating investigator will perform the injections and assess patient safety following the injections.
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KSI-301 5 mg
Arm Type
Experimental
Arm Description
Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol. Drug: Sham Procedure. 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.
Arm Title
Aflibercept 2 mg
Arm Type
Active Comparator
Arm Description
Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. Drug: Sham Procedure. 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.
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
Mean change in Best Corrected Visual Acuity (BCVA) from Day 1.
Description
BCVA is measured using ETDRS visual acuity charts.
Time Frame
Year 1
Secondary Outcome Measure Information:
Title
Proportion of subjects on a Q12W, Q16W or Q20W dosing regimen of KSI-301.
Time Frame
Year 1
Title
Proportion of subjects who gain ≥ 5, ≥10 and ≥15 letters from Day 1.
Time Frame
Year 1
Title
Proportion of subjects who lose ≥ 5, ≥10 and ≥15 letters from Day 1.
Time Frame
Year 1
Title
Proportion of subjects with BCVA Snellen equivalent of 20/40 or better.
Time Frame
Year 1
Title
Proportion of subjects with BCVA Snellen equivalent of 20/200 or worse.
Time Frame
Year 1
Title
Mean change in OCT central subfield retinal thickness (CST) from Day 1.
Time Frame
Year 1
Title
Mean change in OCT intraretinal fluid volume from Day 1.
Time Frame
Year 1
Title
Mean change in OCT subretinal fluid volume from Day 1.
Time Frame
Year 1
Title
Proportion of subjects without intraretinal fluid on OCT.
Time Frame
Year 1
Title
Proportion of subjects without subretinal fluid on OCT.
Time Frame
Year 1
Title
Mean change in CNV total lesion area on FA from baseline.
Time Frame
Year 1
Title
Mean chance in area of leakage on FA from baseline.
Time Frame
Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to participation in the study. Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD. BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive. Other protocol-specified inclusion criteria may apply Exclusion Criteria: CNV secondary to other causes in the Study Eye. Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid. Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss. Active ocular or periocular infection or inflammation. Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye. Uncontrolled glaucoma in the Study Eye. Women who are pregnant or lactating or intending to become pregnant during the study. Stroke or myocardial infarction in the 6-month period prior to Day 1. Uncontrolled blood pressure defined as a systolic value > 180 mmHg or diastolic value ≥100 mmHg while at rest. 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
Jason Ehrlich, MD, PhD
Organizational Affiliation
Kodiak Sciences Inc
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Northwest Arkansas Retina Associates
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
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
Retina Associates of Orange County
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
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
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
Florida Eye Microsurgical Institute
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Retina Associates of Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
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
Cumberland Valley Retina Consultants PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
New England Retina Consultants
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
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
Springfield Clinic LLP
City
Springfield
State/Province
Missouri
ZIP/Postal Code
62703
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
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
Cleveland Clinic Foundation, Cole Eye Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Retina and Vitreous Center of Southern Oregon PC
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
Facility Name
Cascade Medical Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Retina Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Wills Eye Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Palmetto Retina Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Charleston Neuroscience Institute
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
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
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 Clinical Research, LLC
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 Consultants of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
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
Axon Clinical, s.r.o.
City
Praha
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Riga Eastern Clinical University Hospital Clinic Bikernieki
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Oftalmika Sp. z o.o.
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
Facility Name
Gabinet Okulistyczny prof. E. Wylegala
City
Katowice
ZIP/Postal Code
40-760
Country
Poland
Facility Name
Retina Okulistyka Sp. z o.o. Sp. km.
City
Warszawa
ZIP/Postal Code
01-364
Country
Poland
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
821 01
Country
Slovakia
Facility Name
Nemocnica Trebisov - SVET ZDRAVIA - PPDS
City
Trebišov
ZIP/Postal Code
075 01
Country
Slovakia
Facility Name
Fakultna nemocnica Trencin
City
Trenčín
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou Zilina
City
Žilina
ZIP/Postal Code
012 07
Country
Slovakia
Facility Name
Institut de La Macula i La Retina
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital dos de Maig
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration.

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