Nesvategrast (OTT166) in Diabetic Retinopathy (DR)

Completed · Phase 2

Conditions studied: Diabetic Retinopathy

In brief

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

Key facts

Study ID

NCT05409235

Run by

OcuTerra Therapeutics, Inc.

People needed

225

Starts

2022-07-29

Expected to finish

2023-12-29

Last updated by the study team

2024-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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] NVE < 0.5 DA in 1 + quadrants], in whom PRP and/or anti-VEGF IVT can be safely deferred for at least 6 months per the Investigator
• 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)
• Willing and able to return for all study visits and comply with study-related procedures
• Able to adhere to the study dosing requirements
• Understands and signs the written Informed Consent Form

You may not qualify if…

• CST of > 325 μm
• a. Fluid in the central subfield is allowed so long as CST is ≤325 μm and there is a normal foveal contour as determined by the Central Reading Center
• Any prior focal or grid laser photocoagulation or any prior PRP in the study eye as it pertains to treatment of DME or DR (peripheral retinal hole treated with laser is allowed)
• Eyes with DRSS score 61 with fibrous proliferations at disc or fibrous proliferations elsewhere a. DRSS score 61B with NVE only is allowed. Any sign of fibrosis proliferation is exclusionary
• Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
• Any prior intraocular steroid injection in the study eye, inclusive of Iluvien® and Retisert® a. History of Ozurdex® and triamcinolone use prior to 12 months before study enrollment is allowed
• 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 defined as an IOP > 25 mmHg regardless of concomitant treatment with IOP-lowering medications
• Hypertension defined as systolic > 180 mmHg or > 160 mmHg on 2 consecutive measurements (during the same visit) or diastolic > 100 mmHg
• 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 finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications
• 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 as determined to be significant by the Investigator
• Previous pars plana vitrectomy in the study eye
• Any intraocular surgery in the study eye within 90 days (3 months) prior to study enrollment
• 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, including dry eye or glaucoma medications, unless on a stable dose for at least 90 days prior to study enrollment and expected to stay on stable dose throughout study participation. Topical eyedrops are allowed but not within ±10 minutes of study drop application
• 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 (peripheral processes are not exclusionary)
• 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

Where it is running

• Clinical Site 150 — Phoenix, Arizona, United States
• Clinical Site 111 — Beverly Hills, California, United States
• Clinical Site 113 — Encino, California, United States
• Clinical Site 138 — Fresno, California, United States
• Clinical Site 129 — Huntington Beach, California, United States
• Clinical Site 121 — Pasadena, California, United States
• Clinical Site 127 — Pasadena, California, United States
• Clinical Site 142 — Rancho Cordova, California, United States
• Clinical Site 116 — Riverside, California, United States
• Clinical Site 125 — Sacramento, California, United States
• CinCor Site 171 — Torrance, California, United States
• Clinical Site 160 — Walnut Creek, California, United States
• Clinical Site 157 — Coral Springs, Florida, United States
• Clinical Site 106 — Fort Lauderdale, Florida, United States
• Clinical Site 131 — Jacksonville, Florida, United States
• Clinical Site 110 — Miami, Florida, United States
• Clinical Site 153 — St. Petersburg, Florida, United States
• Clinical Site 117 — Winter Haven, Florida, United States
• Clinical Site 112 — ‘Aiea, Hawaii, United States
• Clinical Site 146 — Oak Forest, Illinois, United States
• Clinical Site 128 — Springfield, Illinois, United States
• Clinical Site 154 — Indianapolis, Indiana, United States
• Clinical Site 139 — Lenexa, Kansas, United States
• Clinical Site 166 — Louisville, Kentucky, United States
• Clinical Site 123 — Peoria, Arizona, United States

Full record on ClinicalTrials.gov

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