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

Invirsa

Status and phase: Enrolling; Phase 2

Conditions: Center-involved Diabetic Macular Edema; Non-center Involved Diabetic Macular Edema; Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy; Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy; Diabetic Retinopathy

Treatments: Drug: INV-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT06599684

INV-102-CS-004

Details and patient eligibility

About

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].

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Part 1: INV-102 0.7% in NCIDME

Experimental group

Description:

INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks

Treatment:

Drug: INV-102

Part 2: INV-102 0.7% in CIDME

Experimental group

Description:

INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks

Treatment:

Drug: INV-102