A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD) (DAYLIGHT)

May 26, 2023 updated by: Kodiak Sciences Inc

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 Neovascular (Wet) Age-related Macular Degeneration (wAMD)

This Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 neovascular (wet) age-related macular degeneration (wAMD)

The primary endpoint will be assessed as an average of Weeks 40, 44, and 48; additional secondary endpoints for efficacy will be assessed by visit over time

Study Type

Interventional

Enrollment (Actual)

557

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research & Development Center LLC
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Research Institute, LLC
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Northwest Arkansas Retina Associates
    • California
      • Bakersfield, California, United States, 93309
        • California Retina Consultants
      • Fresno, California, United States, 93720
        • Eye Medical Center of Fresno
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • La Jolla, California, United States, 92037
        • UCSD Jacobs Retina Center
      • Laguna Hills, California, United States, 92653
        • Retina Associates of Orange County
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
      • Poway, California, United States, 92064
        • Retina Consultants of San Diego
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Sacramento, California, United States, 95819
        • Retinal Consultants Medical Group Inc
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates PC
    • Connecticut
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Florida Eye Microsurgical Institute
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute
      • Fort Myers, Florida, United States, 33912
        • National Ophthalmic Research Institute
      • Fort Myers, Florida, United States, 33907
        • Retina Health Center
      • Melbourne, Florida, United States, 32901
        • Florida Eye Associates
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute
      • Saint Petersburg, Florida, United States, 33703
        • Retina Vitreous Associates of Florida
      • Tampa, Florida, United States, 33609
        • Retina Associates of Florida
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic LLP
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Talley Eye
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Retina Associates PA
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Retina Associates of Kentucky
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Retina Group of Washington
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
      • Springfield, Massachusetts, United States, 01103
        • New England Retina Consultants
      • Worcester, Massachusetts, United States, 01603
        • Vitreo Retinal Associates PC
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Foundation for Vision Research
      • Royal Oak, Michigan, United States, 78073
        • Associated Retinal Consultants PC
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Vitreoretinal Surgery PA
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07017
        • The Retina Center of New Jersey
      • Teaneck, New Jersey, United States, 07605
        • NJ Retina
    • New York
      • Liverpool, New York, United States, 13088
        • Retina-Vitreous Surgeons of Central NY
      • Rochester, New York, United States, 14620
        • Retina Associates of Western NY
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Western Carolina Retinal Associate PA
    • Ohio
      • Cleveland, Ohio, United States, 44130
        • Retina Associates of Cleveland
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation, Cole Eye Institute
    • Oregon
      • Portland, Oregon, United States, 97210
        • Retina Northwest
      • Salem, Oregon, United States, 97302
        • Retina Consultants, LLC
      • Springfield, Oregon, United States, 97477
        • Cascade Medical Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • MidAtlantic Retina
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Retina Research of Beaufort
      • Ladson, South Carolina, United States, 29456
        • Charleston Neuroscience Institute
      • West Columbia, South Carolina, United States, 296169
        • Palmetto Retina Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Southeastern Retina Associates PC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina PC
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Houston, Texas, United States, 77030
        • Retina Consultants of Texas
      • Katy, Texas, United States, 77494
        • Retina Consultants of Texas-(Katy)
      • Plano, Texas, United States, 75075
        • Texas Retina Associates
      • Round Rock, Texas, United States, 78681
        • Austin Retina Associates (Round Rock)
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas - (Woodlands)
      • Willow Park, Texas, United States, 76087
        • Strategic Clinical Research Group, LLC
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Eye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent prior to participation in the study.
  • Treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
  • BCVA ETDRS score between 83 and 25 letters, inclusive, in the Study Eye.
  • Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
  • Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

  • BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
  • Active or suspected ocular or periocular infection or inflammation.
  • CNV secondary to other causes in the Study Eye.
  • Any history or evidence of a concurrent ocular condition present in the Study Eye, that in the opinion of the Investigator could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study.
  • Uncontrolled glaucoma in the Study Eye.
  • Significant media opacities, including cataract, in the Study Eye that might interfere with visual acuity, assessment of safety, OCT or fundus photography.
  • Cataract in the Study Eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of screening.
  • Women who are pregnant or lactating or intending to become pregnant during the study.
  • 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.
  • Uncontrolled blood pressure defined as a systolic value ≥180 mmHg or diastolic value ≥100 mmHg while at rest.
  • Other protocol-specified exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KSI-301 (Treatment Group A)
Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.
Drug: KSI-301
Intravitreal Injection
Active Comparator: Aflibercept (Treatment Group B)
Intravitreal injection of aflibercept (2 mg) once every 4 weeks for 3 monthly doses followed by intravitreal injection of aflibercept (2 mg) once every 8 weeks from Week 16 to Week 44. Sham injections will be administered at each monthly visit where an active treatment is not administered.
Drug: Aflibercept
Intravitreal Injection
Other Names:
  • Eylea
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority of KSI-301 to aflibercept measured by changes in BCVA.
Time Frame: Day 1 to Week 48
Demonstrate that KSI-301 5 mg is non-inferior to aflibercept 2 mg with respect to mean change in best-corrected visual acuity (BCVA).
Day 1 to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA
Time Frame: Day 1 to Week 48
Change from baseline in best corrected visual acuity (BCVA) between the two treatment arms.
Day 1 to Week 48
Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on OCT-CST
Time Frame: Day 1 to Week 48
Change from baseline in central subfield thickness (CST) between the two treatment arms.
Day 1 to Week 48
Safety and tolerability of KSI-301 5 mg compared to aflibercept 2 mg based on the number of ocular and systemic adverse events
Time Frame: Day 1 to Week 52
Incidence of ocular and systemic adverse events between the two treatment arms.
Day 1 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kodiak Sciences Inc

Investigators

  • Study Director: Pablo Velazquez-Martin, MD, Kodiak Sciences Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Actual)

March 28, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 6, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS301P107

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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