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.

NCT04049266 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: KSI-CL-102
• Study Type: interventional
• Target: 559
• Locations: 7 countries
• Sites: 75

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1

  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.

  Year 1

Secondary Outcomes (5)

• Percentage of Subjects on KSI-301 Arm With a Once Every 12-Weeks, 16-Weeks or 20-Weeks Treatment Interval

  Year 1

• Percentage of Subjects Gaining ≥ 5, ≥10 and ≥15 Letters in BCVA From Baseline in the Study Eye, Full Analysis Set Year 1

  Year 1

• Percentage of Subjects Who Achieving BCVA Snellen Equivalent of 20/40 or Better in the Study Eye at Year 1

  Year 1

• Percentage of Subjects With BCVA Snellen Equivalent of 20/200 or Worse in the Study Eye at Year 1

  Year 1

• Mean Change in OCT Central Subfield Retinal Thickness (CST) From Day 1

  Year 1

Study Arms (2)

KSI-301 5 mg

EXPERIMENTAL

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: KSI-301; Other: Sham Procedure

Aflibercept 2 mg

ACTIVE COMPARATOR

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.

Drug: Aflibercept; Other: Sham Procedure

Interventions

KSI-301 DRUG

Intravitreal Injection

KSI-301 5 mg

Aflibercept DRUG

Intravitreal Injection

Also known as: Eylea

Aflibercept 2 mg

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 2 mg; KSI-301 5 mg

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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kodiak Sciences Inc: lead

Study Sites (75)

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

Retina Vitreous Associates

Beverly Hills, California, 90211, 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

Retinal Consultants Medical Group Inc

Sacramento, California, 95819, United States

Location

Orange County Retina Medical Group

Santa Ana, California, 92705, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

Colorado Retina Associates PC

Lakewood, Colorado, 80228, 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

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Retina Associates PA

Lenexa, Kansas, 66215, United States

Location

Vitreo Retinal Consultants and Surgeons

Wichita, Kansas, 67214, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740, 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

Springfield Clinic LLP

Springfield, Missouri, 62703, 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 Associates of Cleveland

Beachwood, Ohio, 44122, 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 and Vitreous Center of Southern Oregon PC

Ashland, Oregon, 97520, United States

Location

Cascade Medical Research Institute

Eugene, Oregon, 97401, United States

Location

Retina Northwest

Portland, Oregon, 97210, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Palmetto Retina Center

Florence, South Carolina, 29501, United States

Location

Charleston Neuroscience Institute

Ladson, South Carolina, 29456, 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 Clinical Research, LLC

Austin, Texas, 78705, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, 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

Axon Clinical, s.r.o.

Prague, 150 00, Czechia

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Uniklinik Köln

Cologne, 50937, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitatsklinikum Leipzig

Leipzig, 04103, Germany

Location

Pauls Stradins Clinical University Hospital

Riga, 1002, Latvia

Location

Riga Eastern Clinical University Hospital Clinic Bikernieki

Riga, 1038, Latvia

Location

Oftalmika Sp. z o.o.

Bydgoszcz, 85-631, Poland

Location

Gabinet Okulistyczny prof. E. Wylegala

Katowice, 40-760, Poland

Location

Retina Okulistyka Sp. z o.o. Sp. km.

Warsaw, 01-364, Poland

Location

Univerzitna nemocnica Bratislava

Bratislava, 821 01, Slovakia

Location

Nemocnica Trebisov - SVET ZDRAVIA - PPDS

Trebišov, 075 01, Slovakia

Location

Fakultna nemocnica Trencin

Trenčín, 911 01, Slovakia

Location

Fakultna nemocnica s poliklinikou Zilina

Žilina, 012 07, Slovakia

Location

Institut de La Macula i La Retina

Barcelona, 08022, Spain

Location

Hospital dos de Maig

Barcelona, 08025, Spain

Location

MeSH Terms

Conditions

Wet Macular Degeneration; 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

Limitations and Caveats

This study was terminated early by the Sponsor because the study did not meet the primary endpoint. Thus, not all participants in this study completed the full duration of treatment.

Results Point of Contact

• Title: Pablo Velazquez-Martin, MD
• 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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: October 8, 2019
• Primary Completion: November 17, 2021
• Study Completion: April 26, 2022
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1); DE (4); PL (3); US (59); LA (2); SL (4); ES (2)