Your session is about to expire
← 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 48
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 moreOther 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 • NCT0459241911%
COVID-19
11%
Hypertension
9%
Conjunctival haemorrhage
8%
Conjunctival haemorrhage - Study eye
3%
Retinal Vein Occlusion
1%
Retinal detachment
1%
Urinary tract infection
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- There may be additional requirements for participation in the study, based on the study's specific guidelines.You have a certain level of diabetic retinopathy in your study eye, and the treatment involving laser therapy can be delayed for at least 6 months.You have received prior PRP treatment in the eye being studied.You have specific eye conditions, such as bleeding or retinal detachment, in the eye being studied.You have received a specific type of eye treatment for diabetic eye disease in the study eye before.You have had a steroid injection in your eye for diabetic retinopathy or diabetic macular edema before.You have previously used an experimental treatment directly injected into the eye for diabetic retinopathy or diabetic macular edema in the eye being studied.You have an ongoing or suspected eye infection or inflammation.You have either type 1 or type 2 diabetes.Your blood pressure is very high and not well controlled, with a systolic value of 180 or higher, or a diastolic value of 100 or higher.You have a specific level of eye disease where a certain type of treatment can be delayed for at least 6 months.Your HbA1c level is less than or equal to 12%.Your vision score in the study eye is 69 letters or more, which is about 20/40 or better on the eye chart.The study eye has diabetic macular edema that affects the center of the eye.
Research Study Groups:
This trial has the following groups:- Group 1: KSI-301 - Treatment Group A
- Group 2: Treatment Group B
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05066230 — Phase 3
Other Trials to Consider
Popular Categories
Learn More About These Treatments
Share this study with friends
Copy Link
Messenger