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

Phase

Condition

Retina

Macular Edema

Diabetic Retinopathy

Treatment

INV-102

Clinical Study ID

NCT06599684

INV-102-CS-004

Ages 18-75
All Genders

Study 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].

Eligibility Criteria

Inclusion

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

Exclusion

Key Exclusion Criteria:

Prior laser treatment for DR in the study eye within 12 months from Screening Visit

Study Design