OTT166 in Diabetic Retinopathy (DR)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    210
  • sponsor
    OcuTerra Therapeutics, Inc.
Updated on 11 August 2022
diabetes
edema
vegf
vascular endothelial growth factor
macular edema
ophthalmic solution
severe nonproliferative diabetic retinopathy

Summary

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

Description

This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) and participants who do not have center-involved diabetic macular edema (CI-DME) will be randomized into the following groups:

OTT166 Cohort 1, OTT166 Cohort 2, Vehicle control Cohort 1, Vehicle control Cohort 2.

Details
Condition Diabetic Retinopathy
Treatment Vehicle Control, OTT166
Clinical Study IdentifierNCT05409235
SponsorOcuTerra Therapeutics, Inc.
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

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)
Treatment-naïve (ie, no previous anti-VEGF or steroid treatment or PRP or laser within 1,000 μm diameter of the foveal center/treatment for macular edema or DR in the study eye)

Exclusion Criteria

Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye
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 > 10.0%
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
CST of > 300 μm
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