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)

NCT04964089 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: KS301P107
• Study Type: interventional
• Target: 557
• Locations: 2 countries
• Sites: 66

Brief Summary

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)

Conditions

Wet Age-related Macular Degeneration

Keywords

AMD; Wet AMD; neovascularization secondary to age-related macular degeneration; KSI-301; Aflibercept; Vascular endothelial growth factor; VEGF; Anti-VEGF; Antibody biopolymer conjugate; Macular Degeneration; wAMD; Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders; Vision, Low; Kodiak

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48.

  Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity.

  Day 1 to Week 48

Secondary Outcomes (6)

• Mean Change in Best Corrected Visual Acuity (BCVA) by Visit Over Time

  Day 1 to Week 48

• Proportion of Patients Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time

  Day 1 to Week 48

• Proportion of Patients Who Lost ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time

  Day 1 to Week 48

• Proportion of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters)

  Day 1 to Week 48

• Proportion of Participants With BCVA Snellen Equivalent of 20/200 or Worse Over Time (≤38 ETDRS Letters)

  Day 1 to Week 48

Study Arms (2)

KSI-301 (Treatment Group A)

EXPERIMENTAL

Intravitreal injection of KSI-301 (5 mg) at Day 1 once every 4 weeks via intravitreal injection through Week 44.

Drug: KSI-301

Aflibercept (Treatment Group B)

ACTIVE COMPARATOR

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; Other: Sham Procedure

Interventions

KSI-301 DRUG

Intravitreal Injection

KSI-301 (Treatment Group A)

Aflibercept DRUG

Intravitreal Injection

Also known as: Eylea

Aflibercept (Treatment Group B)

Sham Procedure OTHER

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.

Aflibercept (Treatment Group B)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kodiak Sciences Inc: lead

Study Sites (66)

Retinal Research Institute, LLC

Phoenix, Arizona, 85014, United States

Location

Northwest Arkansas Retina Associates

Springdale, Arkansas, 72762, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Eye Medical Center of Fresno

Fresno, California, 93720, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

UCSD Jacobs Retina Center

La Jolla, California, 92037, United States

Location

Retina Associates of Orange County

Laguna Hills, California, 92653, United States

Location

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

Retina Consultants of San Diego

Poway, California, 92064, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

Retinal Consultants Medical Group Inc

Sacramento, California, 95819, United States

Location

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

Colorado Retina Associates PC

Lakewood, Colorado, 80228, United States

Location

Retina Group of New England

Waterford, Connecticut, 06385, United States

Location

Florida Eye Microsurgical Institute

Boynton Beach, Florida, 33426, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Retina Health Center

Fort Myers, Florida, 33907, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, 33912, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33703, United States

Location

Retina Associates of Florida

Tampa, Florida, 33609, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Springfield Clinic LLP

Springfield, Illinois, 62703, United States

Location

Talley Eye

Evansville, Indiana, 47710, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Retina Associates PA

Lenexa, Kansas, 66215, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

Retina Group of Washington

Chevy Chase, Maryland, 20815, United States

Location

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

New England Retina Consultants

Springfield, Massachusetts, 01103, United States

Location

Vitreo Retinal Associates PC

Worcester, Massachusetts, 01603, United States

Location

Foundation for Vision Research

Grand Rapids, Michigan, 49525, United States

Location

Associated Retinal Consultants PC

Royal Oak, Michigan, 78073, United States

Location

Vitreoretinal Surgery PA

Edina, Minnesota, 55435, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

The Retina Center of New Jersey

Bloomfield, New Jersey, 07017, United States

Location

NJ Retina

Teaneck, New Jersey, 07605, United States

Location

Retina-Vitreous Surgeons of Central NY

Liverpool, New York, 13088, United States

Location

Retina Associates of Western NY

Rochester, New York, 14620, United States

Location

Western Carolina Retinal Associate PA

Asheville, North Carolina, 28803, United States

Location

Retina Associates of Cleveland

Cleveland, Ohio, 44130, United States

Location

Cleveland Clinic Foundation, Cole Eye Institute

Cleveland, Ohio, 44195, United States

Location

Retina Northwest

Portland, Oregon, 97210, United States

Location

Retina Consultants, LLC

Salem, Oregon, 97302, United States

Location

Cascade Medical Research Institute

Springfield, Oregon, 97477, United States

Location

MidAtlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Retina Research of Beaufort

Beaufort, South Carolina, 29902, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 296169, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Southeastern Retina Associates PC

Knoxville, Tennessee, 37909, United States

Location

Tennessee Retina PC

Nashville, Tennessee, 37203, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Houston, Texas, 77030, United States

Location

Retina Consultants of Texas-(Katy)

Katy, Texas, 77494, United States

Location

Texas Retina Associates

Plano, Texas, 75075, United States

Location

Austin Retina Associates (Round Rock)

Round Rock, Texas, 78681, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas - (Woodlands)

The Woodlands, Texas, 77384, United States

Location

Strategic Clinical Research Group, LLC

Willow Park, Texas, 76087, United States

Location

Spokane Eye

Spokane, Washington, 99204, United States

Location

Emanuelli Research & Development Center LLC

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Conditions

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders; Vision, Low

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pablo Velazquez-Martin
• Organization: Kodiak Sciences Inc

ClinOps@kodiak.com

1 (650) 281-0850

Study Officials

• Pablo Velazquez-Martin, MD

  Kodiak Sciences Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 15, 2021
• Study Start: June 23, 2021
• Primary Completion: March 28, 2023
• Study Completion: April 6, 2023
• Last Updated: July 3, 2024
• Results First Posted: May 2, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (65); PR (1)