← Back to Search

Anti-VEGF Monoclonal Antibody

KSI-301 for Diabetic Retinopathy (GLOW Trial)

Phase 3
Waitlist Available
Research Sponsored by Kodiak Sciences Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to week 48
Awards & highlights
Pivotal Trial

Summary

This trial tests KSI-301, an eye injection, in people with severe diabetic eye disease. The medication aims to protect and repair retinal blood vessels to prevent vision loss.

Eligible Conditions
  • Diabetic Retinopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Patients Improving ≥2 Steps on DRSS
Secondary study objectives
Percentage of Patients Developing Any Sight-Threatening Complication
Percentage of Patients Developing DME
Percentage of Patients Developing PDR
+8 more
Other study objectives
Mean Change in BCVA
Mean Change in OCT CST
Time to First Development of DME

Side effects data

From 2023 Phase 3 trial • 568 Patients • NCT04592419
11%
COVID-19
11%
Hypertension
9%
Conjunctival haemorrhage
8%
Conjunctival haemorrhage - Study eye
3%
Retinal Vein Occlusion
1%
Urinary tract infection
1%
Retinal detachment
1%
Atrial fibrillation
1%
Acute myocardial infarction
1%
Haemorrhagic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
KSI-301 (Arm A)
Aflibercept (Arm B)
KSI-301 5mg Extension Phase

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KSI-301 - Treatment Group AExperimental Treatment1 Intervention
Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92
Group II: Treatment Group BPlacebo Group1 Intervention
Sham injection on the same schedule as Treatment Group A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
KSI-301
2020
Completed Phase 3
~1130

Find a Location

Who is running the clinical trial?

Kodiak Sciences IncLead Sponsor
8 Previous Clinical Trials
3,649 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
250 Patients Enrolled for Diabetic Retinopathy
Min Tsuboi, Pharm.D.Study DirectorKodiak Sciences Inc
Pablo Velazquez-Martin, MDStudy DirectorKodiak Sciences Inc
8 Previous Clinical Trials
3,649 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
250 Patients Enrolled for Diabetic Retinopathy

Media Library

KSI-301 (Anti-VEGF Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05066230 — Phase 3
Diabetic Retinopathy Research Study Groups: KSI-301 - Treatment Group A, Treatment Group B
Diabetic Retinopathy Clinical Trial 2023: KSI-301 Highlights & Side Effects. Trial Name: NCT05066230 — Phase 3
KSI-301 (Anti-VEGF Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05066230 — Phase 3
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05066230 — Phase 3
~60 spots leftby Dec 2025