CompletedPhase 2

Study of INV-102 Ophthalmic Solution in Adults With Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy

United States19 participantsStarted 2024-09-07

Plain-language summary

Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR \[Part 1\] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR \[Part 2\].

Who can participate

Age range18 Years – 75 Years

SexALL

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

Key Inclusion Criteria: * Male or female subjects ≥ 18 years of age and \< 76 years of age * Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0% * Study eye must have NCIDME (Part 1) or CIDME (Part 2) * Study eye must be moderate to severe NPDR Key Exclusion Criteria: * Prior laser treatment for DR in the study eye within 12 months from Screening Visit

What they're measuring

Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score

Timeframe: Day 84 (Part 1) and Day 56 (Part 2)

Change from baseline in central subfield thickness (Part 2 only)

Timeframe: Day 56

Trial details

NCT IDNCT06599684

SponsorInvirsa, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Non-center Involved Diabetic Macular Edema trials