NCT06599684

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

Phase 2a Pilot, Open Label, Multicenter, Study of INV-102 Ophthalmic Solution in Subjects With Diabetic Macular Edema (DME) Associated With Non-proliferative Diabetic Retinopathy (NPDR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Invirsa, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 \[Part 2\].

Conditions

• 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

Interventions

Type	Name	Description
DRUG	INV-102	0.7% Ophthalmic Solution

Timeline

• Start date: 2024-09-07
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-09-19
• Last updated: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study