Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05066230
Recruitment Status : Recruiting
First Posted : October 4, 2021
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Kodiak Sciences Inc

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).

Condition or disease Intervention/treatment Phase
Non-proliferative Diabetic Retinopathy Drug: KSI-301 Other: Sham injection Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
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
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)
Actual Study Start Date : August 30, 2021
Estimated Primary Completion Date : November 1, 2023
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine


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.




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

Secondary Outcome Measures :
  1. 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 ]
  2. Time to development of a Sight-Threatening Complication(s) of DR, as a composite and individually [ Time Frame: Day 1 to Week 96 ]
  3. Proportion of eyes improving ≥2 or ≥3 steps on the DRSS over time [ Time Frame: Day 1 to Week 48 and Week 96 ]
  4. Proportion of eyes worsening ≥2 or ≥3 steps on the DRSS over time [ Time Frame: Day 1 to Week 48 and Week 96 ]
  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05066230


Contacts
Layout table for location contacts
Contact: Kodiak Sciences Inc. (650) 281-0850 ksi301clinical@kodiak.com

Locations
Show Show 59 study locations
Sponsors and Collaborators
Kodiak Sciences Inc
Investigators
Layout table for investigator information
Study Director: Min Tsuboi, Pharm.D. Kodiak Sciences Inc
Study Director: Daniel Janer, MD Kodiak Sciences Inc
Layout table for additonal information
Responsible Party: Kodiak Sciences Inc
ClinicalTrials.gov Identifier: NCT05066230    
Other Study ID Numbers: KS301P106
First Posted: October 4, 2021    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kodiak Sciences Inc:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases