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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)

Primary Purpose

Non-proliferative Diabetic Retinopathy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
KSI-301
Sham injection
Sponsored by
Kodiak Sciences Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-proliferative Diabetic Retinopathy focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retinal Research Institute, LLC
  • Retina Vitreous Associates
  • Retina Consultants of Orange County
  • Retina Consultants of Southern California
  • Retinal Consultants Medical Group Inc
  • California Retina Consultants - Santa Maria
  • Connecticut Eye Consultants
  • Retina Group of New England
  • The Macula Center/ Blue Ocean Clinical Research
  • Retina Group of Florida
  • Florida Eye Associates
  • Med Eye Associates
  • Florida Retina Institute
  • Center for Retina & Macular Disease
  • Southeast Retina Center
  • Retina Specialists of Idaho
  • University of Chicago
  • Springfield Clinic LLP
  • Retina Associates PA
  • Cumberland Valley Retina Consultants PC
  • Foundation for Vision Research
  • Sierra Eye Associates
  • Envision Ocular LLC
  • Long Island Vitreoretinal Consultants
  • Ophthalmic Consultants of Long Island
  • Graystone Eye
  • Cascade Medical Research Institute
  • MidAtlantic Retina
  • Charleston Neurosciences Institute
  • Charleston Neuroscience Center
  • Southeastern Retina Associates PC
  • Charles Retina Institute
  • Tennessee Retina PC
  • Retina Research Institute of Texas
  • Panhandle Eye Group, LLP
  • Austin Retina Associates
  • Retina Consultants of Texas (Houston)
  • Star Vision Consultants
  • Retina Consultants of Texas (Katy)
  • Texas Retina Associates
  • Austin Retina Associates (Round Rock)
  • Medical Center Ophthalmology Associates
  • Retina Consultants of San Antonio
  • Retina Consultants of Texas - (Woodlands)
  • Piedmont Eye Center
  • Spokane Eye
  • Emanuelli Research & Development Center LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

KSI-301 - Treatment Group A

Treatment Group B

Arm Description

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

Sham injection on the same schedule as Treatment Group A

Outcomes

Primary Outcome Measures

Proportion of eyes improving ≥2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS)

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2021
Last Updated
September 22, 2022
Sponsor
Kodiak Sciences Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05066230
Brief Title
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)
Acronym
GLOW
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kodiak Sciences Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KSI-301 - Treatment Group A
Arm Type
Experimental
Arm Description
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
Arm Title
Treatment Group B
Arm Type
Sham Comparator
Arm Description
Sham injection on the same schedule as Treatment Group A
Intervention Type
Drug
Intervention Name(s)
KSI-301
Intervention Description
Intravitreal injection
Intervention Type
Other
Intervention Name(s)
Sham injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of eyes improving ≥2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS)
Time Frame
Day 1 to Week 48
Secondary Outcome Measure Information:
Title
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
Title
Time to development of a Sight-Threatening Complication(s) of DR, as a composite and individually
Time Frame
Day 1 to Week 96
Title
Proportion of eyes improving ≥2 or ≥3 steps on the DRSS over time
Time Frame
Day 1 to Week 48 and Week 96
Title
Proportion of eyes worsening ≥2 or ≥3 steps on the DRSS over time
Time Frame
Day 1 to Week 48 and Week 96
Title
Safety and Tolerability of KSI-301 5 mg compared to sham treatment
Description
Incidence of ocular and systemic adverse events
Time Frame
Day 1 to Week 100

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pablo Velazquez-Martin, MD
Organizational Affiliation
Kodiak Sciences Inc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Daniel Janer, MD
Organizational Affiliation
Kodiak Sciences Inc
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Vitreous Associates
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Retina Consultants of Southern California
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Retinal Consultants Medical Group Inc
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
California Retina Consultants - Santa Maria
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Connecticut Eye Consultants
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Retina Group of New England
City
Waterford
State/Province
Connecticut
ZIP/Postal Code
06385
Country
United States
Facility Name
The Macula Center/ Blue Ocean Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Med Eye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Center for Retina & Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Retina Specialists of Idaho
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Springfield Clinic LLP
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Retina Associates PA
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Cumberland Valley Retina Consultants PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Foundation for Vision Research
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Envision Ocular LLC
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
Long Island Vitreoretinal Consultants
City
Hauppauge
State/Province
New York
ZIP/Postal Code
11788
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Oceanside
State/Province
New York
ZIP/Postal Code
11572
Country
United States
Facility Name
Graystone Eye
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28603-2588
Country
United States
Facility Name
Cascade Medical Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
MidAtlantic Retina
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017-9412
Country
United States
Facility Name
Charleston Neurosciences Institute
City
Beaufort
State/Province
South Carolina
ZIP/Postal Code
29902
Country
United States
Facility Name
Charleston Neuroscience Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Southeastern Retina Associates PC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Charles Retina Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119-4823
Country
United States
Facility Name
Tennessee Retina PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Panhandle Eye Group, LLP
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants of Texas (Houston)
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Star Vision Consultants
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Facility Name
Retina Consultants of Texas (Katy)
City
Katy
State/Province
Texas
ZIP/Postal Code
77494
Country
United States
Facility Name
Texas Retina Associates
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Austin Retina Associates (Round Rock)
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Texas - (Woodlands)
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Spokane Eye
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Emanuelli Research & Development Center LLC
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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