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

April 9, 2024 updated by: Kodiak Sciences Inc

A Prospective, Randomized, Double-masked, Sham-controlled, Multicenter, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, prospective, randomized, double-masked, sham-controlled, two-arm, multicenter study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with moderately severe to severe non-proliferative diabetic retinopathy (NPDR).

The primary endpoint will be assessed at Week 48; additional secondary endpoints for efficacy will be assessed at Week 48, Week 96 and if applicable, over time.

Study Type

Interventional

Enrollment (Actual)

253

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

  • Czechia
      • Praha 5, Czechia, 15 0 00
        • Axon Clinical, s.r.o.
    • Pardubický Kraj
      • Pardubice, Pardubický Kraj, Czechia, 530 02
        • OFTEX s.r.o.
  • Latvia
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
      • Rīga, Latvia, LV-1009
        • Latvian American Eye Center
  • Poland
      • Bydgoszcz, Poland, 85-631
        • Oftalmika Sp. z o.o.
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 01-258
        • Warszawski Szpital Okulistyczny
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-952
        • Optimum Profesorskie Centrum Okulistyki
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research & Development Center LLC
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou F. D. Roosevelta
      • Trencin, Slovakia, 911 71
        • Fakultna nemocnica Trencin
  • Spain
      • Zaragoza, Spain, 50001
        • Hospital Clínico Universitario Lozano Blesa
      • Zaragoza, Spain, 50006
        • Hospital Universitario Miguel Servet
    • Barcelona
      • L'hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Sant Cugat del Valles, Barcelona, Spain, 08195
        • Hospital Universitari General de Catalunya - Grupo Quironsalud
    • Majadanonda
      • Madrid, Majadanonda, Spain, 28220
        • Hospital Universitario Puerta de Hierro - Majadahonda
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Research Institute, LLC
    • California
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Associates
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County
      • Redlands, California, United States, 92374
        • Retina Consultants of Southern California
      • Sacramento, California, United States, 95825
        • Retinal Consultants Medical Group Inc
      • Santa Maria, California, United States, 93454
        • California Retina Consultants - Santa Maria
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Connecticut Eye Consultants
      • Waterford, Connecticut, United States, 06385
        • Retina Group of New England
    • Florida
      • Clearwater, Florida, United States, 33761
        • The Macula Center/ Blue Ocean Clinical Research
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Melbourne, Florida, United States, 32901
        • Florida Eye Associates
      • Miami, Florida, United States, 33143
        • Med Eye Associates
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
      • Winter Haven, Florida, United States, 33880
        • Center for Retina & Macular Disease
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Southeast Retina Center
    • Idaho
      • Boise, Idaho, United States, 83713
        • Retina Specialists of Idaho
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic LLP
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Retina Associates PA
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Cumberland Valley Retina Consultants PC
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Foundation for Vision Research
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular LLC
    • New York
      • Hauppauge, New York, United States, 11788
        • Long Island Vitreoretinal Consultants
      • Oceanside, New York, United States, 11572
        • Ophthalmic Consultants of Long Island
    • North Carolina
      • Hickory, North Carolina, United States, 28603-2588
        • Graystone Eye
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Cascade Medical Research Institute
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017-9412
        • MidAtlantic Retina
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
        • Charleston Neurosciences Institute
      • Charleston, South Carolina, United States, 29414
        • Charleston Neuroscience Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Southeastern Retina Associates PC
      • Memphis, Tennessee, United States, 38119-4823
        • Charles Retina Institute
      • Nashville, Tennessee, United States, 37203
        • Tennessee Retina PC
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Amarillo, Texas, United States, 79106
        • Panhandle Eye Group, LLP
      • Austin, Texas, United States, 78705
        • Austin Retina Associates
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas (Houston)
      • Burleson, Texas, United States, 76028
        • Star Vision Consultants
      • 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
      • San Antonio, Texas, United States, 78240
        • Retina Consultants of San Antonio
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas - (Woodlands)
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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%.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • 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.
  • 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): three initiating doses, and then every 24 weeks through Week 92
Drug: KSI-301
Intravitreal injection
Sham Comparator: Treatment Group B
Sham injection on the same schedule as Treatment Group A
Other: Sham injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of eyes improving ≥2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS)
Time Frame: Day 1 to Week 48
Day 1 to Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of eyes developing a Sight-Threatening Complication(s) of DR (DME, PDR, ASNV), as a composite and individually
Time Frame: Day 1 to Week 48 and Week 96
Day 1 to Week 48 and Week 96
Time to development of a Sight-Threatening Complication(s) of DR, as a composite and individually
Time Frame: Day 1 to Week 96
Day 1 to Week 96
Proportion of eyes improving ≥2 or ≥3 steps on the DRSS over time
Time Frame: Day 1 to Week 48 and Week 96
Day 1 to Week 48 and Week 96
Proportion of eyes worsening ≥2 or ≥3 steps on the DRSS over time
Time Frame: Day 1 to Week 48 and Week 96
Day 1 to Week 48 and Week 96
Safety and Tolerability of KSI-301 5 mg compared to sham treatment
Time Frame: Day 1 to Week 100
Incidence of ocular and systemic adverse events
Day 1 to Week 100

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 Director: Daniel Janer, 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)

August 30, 2021

Primary Completion (Actual)

August 3, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS301P106

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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