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

Recruiting
18 - 75 years of age
Both
Phase 2

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Overview

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].

Eligibility

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

Study details

Non-center Involved Diabetic Macular Edema, Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy, Diabetic Retinopathy, Center-involved Diabetic Macular Edema, Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy

NCT06599684

Invirsa, Inc.

5 May 2025

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