Phase 2Completed
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)
- Sponsor
- Invirsa, Inc. (Industry)
- Enrolment
- 19 enrolled
- 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
- INV-102
- Ages
- adults, older adults
- Registry
- NCT06599684
Full record on ClinicalTrials.gov
From the registry
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 \[Part 2\].
Primary outcomes
- Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
- Change from baseline in central subfield thickness (Part 2 only)
History
Last registry update
Primary completion
Registered
Started