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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 and week 96
Awards & highlights
GLOW Trial Summary
This trial will study whether KSI-301 is effective and safe for people with moderate to severe diabetic retinopathy.
Eligible Conditions
- Non Proliferative Diabetic Retinopathy
GLOW Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to week 48 and week 96
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to week 48 and week 96
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of eyes improving ≥2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS)
Secondary outcome measures
Proportion of eyes developing a Sight-Threatening Complication(s) of DR (DME, PDR, ASNV), as a composite and individually
Proportion of eyes improving ≥2 or ≥3 steps on the DRSS over time
Proportion of eyes worsening ≥2 or ≥3 steps on the DRSS over time
+2 moreGLOW 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
7 Previous Clinical Trials
2,973 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
5 Previous Clinical Trials
1,847 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has KSI-301 been cleared by the FDA?
"There is available data that supports the efficacy of KSI-301, so it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
New York
Other
Florida
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Retina Consultants of Texas (Houston)
Retina Consultants of Texas - (Woodlands)
Ophthalmic Consultants of Long Island
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
I want to see clearly. I have been to multiple doctors here in Louisiana with no help, i am determined to see again!
PatientReceived no prior treatments
Well every time I go to the doctor say my sugar is a little high but when I check it at home it's really really high I take metformin and another one starts with something like that but it.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Can you help me?
PatientReceived 2+ prior treatments
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