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Completed
NCT06599684
Study of INV-102 Ophthalmic Solution in Adults With Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
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
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 19
Sponsor: Invirsa, Inc.
Location: MedTrials, Inc. Dallas Texas
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
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
Source: ClinicalTrials.gov (NCT06599684). StuddyBuddy aggregates publicly available trial information.
