OTT166 for Diabetic Retinopathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic Retinopathy+1 More
OTT166 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study a new eye solution to see if it is safe and effective in treating diabetic retinopathy.

Eligible Conditions
  • Diabetic Retinopathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: From Baseline (Day 1) up to Week 24

At week 24
Proportion of participants developing worse than mild PDR (DRSS 65 and above)
Proportion of participants who develop ASNV
Proportion of participants who develop CI-DME
Proportion of participants who have improved by ≥ 2 steps from baseline in Diabetic Retinopathy Severity Scale (DRSS) scores
Proportion of participants with change in DRSS steps
Proportion of participants with mild PDR (DRSS score 61) at baseline who regress to NPDR (DRSS score ≤ 53)
Time to development of CI-DME
Time to development of PDR worse than mild (DRSS 65 and above)
Week 24
AUC for change from baseline in CST
Area under the curve (AUC) for change from baseline in BCVA
Change from baseline in DRSS step
Change from baseline in best corrected visual acuity (BCVA)
Change from baseline in central subfield thickness (CST)
Proportion of participants who met the rescue criteria
Proportion of participants with lines gained/lost of BCVA
Time to meet rescue therapy criteria
Week 24
Proportion of participants with treatment-emergent adverse events (TEAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

OTT166 Cohort 2
1 of 4
OTT166 Cohort 1
1 of 4
Vehicle control Cohort 2
1 of 4
Vehicle control Cohort 1
1 of 4
Experimental Treatment
Non-Treatment Group

210 Total Participants · 4 Treatment Groups

Primary Treatment: OTT166 · Has Placebo Group · Phase 2

OTT166 Cohort 2
Drug
Experimental Group · 1 Intervention: OTT166 · Intervention Types: Drug
OTT166 Cohort 1
Drug
Experimental Group · 1 Intervention: OTT166 · Intervention Types: Drug
Vehicle control Cohort 2
Drug
PlaceboComparator Group · 1 Intervention: Vehicle control · Intervention Types: Drug
Vehicle control Cohort 1
Drug
PlaceboComparator Group · 1 Intervention: Vehicle control · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (day 1) up to week 24

Who is running the clinical trial?

OcuTerra Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
88 Total Patients Enrolled
ParexelIndustry Sponsor
268 Previous Clinical Trials
95,036 Total Patients Enrolled
Carl Regillo, MDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have type 1 or 2 diabetes mellitus and moderately to severely diabetic retinopathy.
You have a BCVA of 20/40 or better in the study eye.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 27th, 2021

Last Reviewed: October 14th, 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?
Missouri100.0%
What site did they apply to?
Clinical Site 128100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
3+100.0%