Study of INV-102 Ophthalmic Solution in Adults With Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
NCT06599684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2026-01-27
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
- DRUG
-
INV-102
0.7% Ophthalmic Solution
Sponsors & Collaborators
-
Invirsa, Inc.
lead INDUSTRY
Principal Investigators
-
Robert Shalwitz · Invirsa, Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-07
- Primary Completion
- 2025-09-30
- Completion
- 2025-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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