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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05066230
Recruitment Status : Active, not recruiting
First Posted : October 4, 2021
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
Kodiak Sciences Inc

Tracking Information
First Submitted Date  ICMJE September 23, 2021
First Posted Date  ICMJE October 4, 2021
Last Update Posted Date September 26, 2022
Actual Study Start Date  ICMJE August 30, 2021
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2021)
Proportion of eyes improving ≥2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) [ Time Frame: Day 1 to Week 48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2021)
  • 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 ]
  • Time to development of a Sight-Threatening Complication(s) of DR, as a composite and individually [ Time Frame: 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 ]
  • Proportion of eyes worsening ≥2 or ≥3 steps on the DRSS over time [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Participants With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy (NPDR)
Official Title  ICMJE 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)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized 1:1 into one of two arms: KSI-301 or sham.
Masking: Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE Non-proliferative Diabetic Retinopathy
Intervention  ICMJE
  • Drug: KSI-301
    Intravitreal injection
  • 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.
Study Arms  ICMJE
  • Experimental: KSI-301 - Treatment Group A
    Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
    Intervention: Drug: KSI-301
  • Sham Comparator: Treatment Group B
    Sham injection on the same schedule as Treatment Group A
    Intervention: Other: Sham injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 22, 2022)
253
Original Estimated Enrollment  ICMJE
 (submitted: September 23, 2021)
240
Estimated Study Completion Date  ICMJE November 1, 2024
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05066230
Other Study ID Numbers  ICMJE KS301P106
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kodiak Sciences Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Kodiak Sciences Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pablo Velazquez-Martin, MD Kodiak Sciences Inc
Study Director: Daniel Janer, MD Kodiak Sciences Inc
PRS Account Kodiak Sciences Inc
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP