CompletedPhase 2

Nesvategrast (OTT166) in Diabetic Retinopathy (DR)

United States225 participantsStarted 2022-07-29

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. CST of \> 325 μm
✕. 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

Proportion of Participants Who Improved by ≥ 2 Steps From Baseline in Diabetic Retinopathy Severity Scale (DRSS) Scores

Timeframe: At week 24

NCT IDNCT05409235

SponsorOcuTerra Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-29

Results submitted2024-04-29

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. CST of \> 325 μm
✕. 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