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)
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|ClinicalTrials.gov Identifier: NCT05066230|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2021
Last Update Posted : September 26, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Non-proliferative Diabetic Retinopathy||Drug: KSI-301 Other: Sham injection||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||253 participants|
|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.|
|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|
Experimental: KSI-301 - Treatment Group A
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
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.
- Proportion of eyes improving ≥2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) [ Time Frame: Day 1 to Week 48 ]
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|Study Director:||Pablo Velazquez-Martin, MD||Kodiak Sciences Inc|
|Study Director:||Daniel Janer, MD||Kodiak Sciences Inc|
|Responsible Party:||Kodiak Sciences Inc|
|Other Study ID Numbers:||
|First Posted:||October 4, 2021 Key Record Dates|
|Last Update Posted:||September 26, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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