A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)

NCT05066230 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: KS301P106
• Study Type: interventional
• Target: 253
• Locations: 7 countries
• Sites: 61

Brief Summary

This Phase 3 Study will evaluate the efficacy and safety of KSI-301 in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

Conditions

Non-proliferative Diabetic Retinopathy

Keywords

Non-proliferative Diabetic Retinopathy; Diabetic Retinopathy; NPDR; KSI-301; VEGF; Anti-VEGF; Vascular Endothelial Growth Factor; Antibody Biopolymer Conjugate; Retinal Degeneration; Retinal Diseases; Eye Diseases; Retinopathy; Vision Disorders; Kodiak

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Improving ≥2 Steps on DRSS

  Percentage of patients improving ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).

  Day 1 to Week 48

Secondary Outcomes (11)

• Percentage of Patients Developing Any Sight-Threatening Complication

  Day 1 to Week 48

• Percentage of Patients Improving ≥3 Steps on DRSS

  Day 1 to Week 48

• Percentage of Patients Developing PDR

  Day 1 to Week 48

• Percentage of Patients Developing PDR or ASNV

  Day 1 to Week 48

• Percentage of Patients Developing Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR

  Day 1 to Week 48

Other Outcomes (3)

• Time to First Development of DME

  Day 1 to Week 48

• Mean Change in OCT CST

  Day 1 to Week 48

• Mean Change in BCVA

  Day 1 to Week 48

Study Arms (2)

KSI-301 - Treatment Group A

EXPERIMENTAL

Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92

Drug: KSI-301

Treatment Group B

SHAM COMPARATOR

Sham injection on the same schedule as Treatment Group A

Other: Sham injection

Interventions

KSI-301 DRUG

Intravitreal injection

KSI-301 - Treatment Group A

Sham injection OTHER

The sham injection 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 is performed to maintain masking of the study.

Treatment Group B

Eligibility Criteria

• Age: 18 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.
• Type 1 or 2 diabetes mellitus
• Moderately severe to severe NPDR in the Study Eye (DRSS levels 47 and 53 as determined by the reading center), in which pan-retinal photocoagulation (PRP) can be safely deferred for at least 6 months per the Investigator.
• BCVA ETDRS letter score in the Study Eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
• HbA1c of ≤12%.

You may not qualify if:

• Presence of center-involved DME in the Study Eye
• Prior PRP in the Study Eye.
• Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment in the Study Eye.
• Prior intravitreal anti-VEGF treatment in the Study Eye for DR or DME.
• Prior intravitreal or periocular steroid in the Study Eye for DR or DME.
• Prior use of an investigational intravitreal treatment for DR or DME 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 alter visual acuity during the study
• Active or suspected ocular or periocular infection or inflammation.
• Women who are pregnant or lactating or intending to become pregnant during the study.
• 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.
• 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.
• 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 (61)

Retinal Research Institute, LLC

Phoenix, Arizona, 85014, United States

Location

Retina Vitreous Associates

Beverly Hills, California, 90211, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

Retinal Consultants Medical Group Inc

Sacramento, California, 95825, United States

Location

California Retina Consultants - Santa Maria

Santa Maria, California, 93454, United States

Location

Connecticut Eye Consultants

Danbury, Connecticut, 06810, United States

Location

Retina Group of New England

Waterford, Connecticut, 06385, United States

Location

The Macula Center/ Blue Ocean Clinical Research

Clearwater, Florida, 33761, United States

Location

Retina Group of Florida

Fort Lauderdale, Florida, 33308, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Med Eye Associates

Miami, Florida, 33143, United States

Location

Florida Retina Institute

Orlando, Florida, 32806, United States

Location

Center for Retina & Macular Disease

Winter Haven, Florida, 33880, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Retina Specialists of Idaho

Boise, Idaho, 83713, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Springfield Clinic LLP

Springfield, Illinois, 62703, United States

Location

Retina Associates PA

Lenexa, Kansas, 66215, United States

Location

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740, United States

Location

Foundation for Vision Research

Grand Rapids, Michigan, 49525, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Envision Ocular LLC

Bloomfield, New Jersey, 07003, United States

Location

Long Island Vitreoretinal Consultants

Hauppauge, New York, 11788, United States

Location

Ophthalmic Consultants of Long Island

Oceanside, New York, 11572, United States

Location

Graystone Eye

Hickory, North Carolina, 28603-2588, United States

Location

Cascade Medical Research Institute

Eugene, Oregon, 97401, United States

Location

MidAtlantic Retina

Bethlehem, Pennsylvania, 18017-9412, United States

Location

Charleston Neurosciences Institute

Beaufort, South Carolina, 29902, United States

Location

Charleston Neuroscience Center

Charleston, South Carolina, 29414, United States

Location

Southeastern Retina Associates PC

Knoxville, Tennessee, 37909, United States

Location

Charles Retina Institute

Memphis, Tennessee, 38119-4823, United States

Location

Tennessee Retina PC

Nashville, Tennessee, 37203, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Panhandle Eye Group, LLP

Amarillo, Texas, 79106, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas (Houston)

Bellaire, Texas, 77401, United States

Location

Star Vision Consultants

Burleson, Texas, 76028, 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 San Antonio

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas - (Woodlands)

The Woodlands, Texas, 77384, United States

Location

Piedmont Eye Center

Lynchburg, Virginia, 24502, United States

Location

Spokane Eye

Spokane, Washington, 99204, United States

Location

OFTEX s.r.o.

Pardubice, Pardubický kraj, 530 02, Czechia

Location

Axon Clinical, s.r.o.

Prague, 15 0 00, Czechia

Location

Pauls Stradins Clinical University Hospital

Riga, LV-1002, Latvia

Location

Latvian American Eye Center

Riga, LV-1009, Latvia

Location

Warszawski Szpital Okulistyczny

Warsaw, Masovian Voivodeship, 01-258, Poland

Location

Optimum Profesorskie Centrum Okulistyki

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Oftalmika Sp. z o.o.

Bydgoszcz, 85-631, Poland

Location

Emanuelli Research & Development Center LLC

Arecibo, 00612, Puerto Rico

Location

Fakultna nemocnica s poliklinikou F. D. Roosevelta

Banská Bystrica, 975 17, Slovakia

Location

Fakultna nemocnica Trencin

Trenčín, 911 71, Slovakia

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitari General de Catalunya - Grupo Quironsalud

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, Majadanonda, 28220, Spain

Location

Hospital Clinico Universitario Lozano Blesa

Zaragoza, 50001, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50006, Spain

Location

MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Degeneration; Retinal Diseases; Eye Diseases; Vision Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eye Diseases, Hereditary; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Kodiak Sciences Inc

ClinOps@kodiak.com

1 (650) 281-0850

Study Officials

• Pablo Velazquez-Martin, MD

  Kodiak Sciences Inc

  STUDY DIRECTOR

• Daniel Janer, MD

  Kodiak Sciences Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: To preserve masking, 2 investigators are required for this study. The masked investigator will be responsible for 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 arms: KSI-301 or sham.

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: September 7, 2021
• Primary Completion: August 3, 2023
• Study Completion: August 31, 2023
• Last Updated: September 5, 2024
• Results First Posted: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); US (46); LA (2); PR (1); SL (2); ES (5); PL (3)