OTT166 in Diabetic Retinopathy (DR)

About

Brief Summary

This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion Criteria:

Men or women ≥ 18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR [DRSS levels 47 or 53], or mild PDR [DRSS level 61]
BCVA ETDRS letter score in the study eye of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better)
Normal foveal contour
Treatment naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser)

Exclusion Criteria:

CST of > 325 μm
Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
Eyes with DRSS score 61 due to fibrous proliferations at disc or fibrous proliferations elsewhere
Any prior systemic anti-VEGF intravitreal injection (IVT) or anti-VEGF treatment in the study eye
Any prior intraocular steroid injection in the study eye
Current ASNV, vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
Uncontrolled glaucoma or ocular hypertension in the study eye
Hypertension
Screening HbA1c blood test > 12.0%
Renal failure (stage 4 or end-stage), dialysis, or history of renal transplant
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory
Initiation of intensive insulin treatment (a pump or multiple daily injections) within 4 months prior to randomization or plans to do so in the next 4 months
Epiretinal membrane, posterior hyaloidal traction, and/or vitreomacular traction in the study eye
Previous pars plana vitrectomy in the study eye
Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment
Yttrium Aluminum Garnet (YAG) laser treatment in the study eye within 90 days prior to study enrollment
Concomitant use of any topical ophthalmic medications in the study eye
Contact lens use from time of screening throughout the study
Central corneal changes from dry eye that are visually significant and/or Sjogren's syndrome
Visually significant Fuchs endothelial dystrophy or other diagnosed conditions of corneal compromise including Anterior Basement Membrane Dystrophy, or any corneal dystrophy affecting central vision
Chronic or recurrent uveitis in the study eye
Ongoing ocular infection or inflammation in either eye
A history of cataract surgery complicated by vitreous loss in the study eye
Congenital eye malformations in the study eye
A history of penetrating ocular trauma in the study eye
Cognitive impairment
Women who are breastfeeding or who have a positive serum human chorionic gonadotropin (hCG)/urine pregnancy test at the screening or Baseline (BL) Visit
Ocular media of insufficient quality to obtain fundus photographs, fluorescein angiography, and optical coherence tomography (OCT) images in the study eye
Concomitant use of Semaglutide (Wegovy™, Ozempic®, Rybelsus®) or Thiazolidinediones (Actos®, Avandia®) within 12 months prior to Visit 1 (allowed if a stable dose has been established for at least 1 year of use)

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