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OTT166 for Diabetic Retinopathy

Phase 2
Waitlist Available
Led By Carl Regillo, MD
Research Sponsored by OcuTerra Therapeutics, 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 from baseline (day 1) up to week 24

Summary

This trial is testing OTT166 eye drops to see if they can help people with diabetic retinopathy who haven't had other treatments. The drops aim to protect the retina by preventing harmful changes in blood vessels caused by diabetes.

Who is the study for?
Adults over 18 with type 1 or type 2 diabetes and moderate to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR), who have good vision (20/40 or better) and haven't had previous treatments like anti-VEGF, steroids, laser therapy, or surgery for their eye condition. Participants must not be using certain diabetes medications unless on a stable dose for at least a year.
What is being tested?
The trial is testing OTT166 Ophthalmic solution against a vehicle control to see if it's safe and effective in treating Diabetic Retinopathy. Patients will receive either the study drug or a placebo in their eyes to compare outcomes.
What are the potential side effects?
While specific side effects of OTT166 are not listed here, common side effects from ophthalmic solutions can include eye irritation, redness, discomfort, blurred vision temporarily after application, potential allergic reactions, and rarely more serious eye conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (day 1) up to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (day 1) up to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores
Secondary study objectives
Area Under The Curve (AUC) for Change From Baseline in CST
Area Under the Curve for BCVA (ETDRS Letters) From Baseline to Week 24
Change From Baseline in Best Corrected Visual Acuity (BCVA)
+14 more
Other study objectives
Proportion of Participants That Develop a VTC by Week 24 for DRSS Levels 47 and 53 at Baseline
Proportion of Participants Who Developed CI-DME at Week 24 for Randomization Strata DRSS 47 and 53

Side effects data

From 2023 Phase 2 trial • 225 Patients • NCT05409235
13%
Punctate keratitis
8%
Hypertension
7%
Diabetic retinopathy
5%
Diabetic retinal oedema
5%
Retinal neovascularisation
4%
Cataract
3%
Dysgeusia
1%
Diarrhoea
1%
Hypotension
1%
Alcohol abuse
1%
Vertigo
1%
Accelerated hypertension
1%
Constipation
1%
Pneumonia
1%
Spinal stenosis
1%
Cranial nerve paralysis
1%
Headache
1%
Dry eye
1%
Pancreatic carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
OTT166 Cohort 1
OTT166 Cohort 2
Vehicle Control Cohort 1
Vehicle Control Cohort 2

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: OTT166 Cohort 2Experimental Treatment1 Intervention
Participants will receive OTT166 5% four times a day (QID) for 24 weeks
Group II: OTT166 Cohort 1Experimental Treatment1 Intervention
Participants will receive OTT166 5% twice a day (BID) for 24 weeks
Group III: Vehicle control Cohort 1Placebo Group1 Intervention
Participants will receive vehicle control BID for 24 weeks
Group IV: Vehicle control Cohort 2Placebo Group1 Intervention
Participants will receive vehicle control QID for 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OTT166
2022
Completed Phase 2
~230

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Diabetic Retinopathy (DR) include anti-VEGF (vascular endothelial growth factor) injections, corticosteroids, and laser therapy. Anti-VEGF treatments, such as ranibizumab and aflibercept, work by inhibiting the growth of abnormal blood vessels and reducing vascular permeability, which helps to prevent vision loss. Corticosteroids reduce retinal inflammation and edema, thereby improving visual acuity. Laser therapy seals leaking blood vessels and reduces the risk of further hemorrhage. These treatments are crucial for DR patients as they address the underlying pathophysiological processes of inflammation and abnormal blood vessel growth, which are key contributors to vision impairment in DR.

Find a Location

Who is running the clinical trial?

ParexelIndustry Sponsor
308 Previous Clinical Trials
100,663 Total Patients Enrolled
OcuTerra Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
88 Total Patients Enrolled
Carl Regillo, MDPrincipal InvestigatorPrincipal Investigator
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

OTT166 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05409235 — Phase 2
Diabetic Retinopathy Research Study Groups: Vehicle control Cohort 1, OTT166 Cohort 1, Vehicle control Cohort 2, OTT166 Cohort 2
Diabetic Retinopathy Clinical Trial 2023: OTT166 Highlights & Side Effects. Trial Name: NCT05409235 — Phase 2
OTT166 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05409235 — Phase 2
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05409235 — Phase 2
~71 spots leftby Oct 2025