KSI-301 for Diabetic Retinopathy

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Diabetic Retinopathy+2 More
KSI-301 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study whether KSI-301 is effective and safe for people with moderate to severe diabetic retinopathy.

Eligible Conditions
  • Diabetic Retinopathy
  • Non-proliferative Diabetic Retinopathy

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Day 1 to Week 48 and Week 96

Week 100
Safety and Tolerability of KSI-301 5 mg compared to sham treatment
Week 48
Proportion of eyes improving ≥2 steps on the ETDRS Diabetic Retinopathy Severity Scale (DRSS)
Week 96
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
Week 96
Time to development of a Sight-Threatening Complication(s) of DR, as a composite and individually

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

KSI-301 - Treatment Group A
1 of 2
Treatment Group B
1 of 2

Experimental Treatment

Non-Treatment Group

253 Total Participants · 2 Treatment Groups

Primary Treatment: KSI-301 · Has Placebo Group · Phase 3

KSI-301 - Treatment Group A
Drug
Experimental Group · 1 Intervention: KSI-301 · Intervention Types: Drug
Treatment Group B
Other
ShamComparator Group · 1 Intervention: Sham injection · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to week 48 and week 96

Who is running the clinical trial?

Kodiak Sciences IncLead Sponsor
6 Previous Clinical Trials
2,723 Total Patients Enrolled
Min Tsuboi, Pharm.D.Study DirectorKodiak Sciences Inc
Daniel Janer, MDStudy DirectorKodiak Sciences Inc
1 Previous Clinical Trials
568 Total Patients Enrolled
Pablo Velazquez-Martin, MDStudy DirectorKodiak Sciences Inc
3 Previous Clinical Trials
1,476 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have type 1 or type 2 diabetes mellitus.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 17th, 2021

Last Reviewed: November 29th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas75.0%
Florida12.5%
New York12.5%
How old are they?
18 - 6575.0%
65+25.0%
What site did they apply to?
Retina Consultants of Texas (Houston)50.0%
Retina Consultants of Texas - (Woodlands)25.0%
Ophthalmic Consultants of Long Island25.0%
What portion of applicants met pre-screening criteria?
Met criteria75.0%
Did not meet criteria25.0%