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

Phase 2

Recruiting

• 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

• Registration Number: NCT06599684
• Lead Sponsor: Invirsa, Inc.

Brief 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 \[Part 2\].

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-07
• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-13
• Study First Posted: 2024-09-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1: INV-102 0.7% in NCIDME	INV-102	INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks
Part 2: INV-102 0.7% in CIDME	INV-102	INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score	Day 84 (Part 1) and Day 56 (Part 2)	Graded by an independent central reading center using Wide-field Color Fundus Photography. The DRSS divides diabetic retinopathy into levels ranging from absence of retinopathy (score = 10) to advanced retinopathy (score = 85). The scale is used to describe overall retinopathy severity as well as the change in severity over time.
Change from baseline in central subfield thickness (Part 2 only)	Day 56	Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in macular volume	Day 84 (Part 1) and Day 56 (Part 2)	Measured using spectral domain optical coherence tomography (SD-OCT)
Change from baseline in subfield thickness	Day 84 (Part 1) and Day 56 (Part 2)	Mean retinal thickness in each of the regional subfields of the ETDRS grid, measured using SD-OCT
Change from baseline in the retinal thickness at the thickest point of the subfield thickness	Day 84 (Part 1) and Day 56 (Part 2)	Measured using SD-OCT in each of the regional subfields of the ETDRS grid
Change in best corrected visual acuity (BCVA) (Part 2 only)	Day 56

Trial Locations

Locations (1)

MedTrials, Inc.; 🇺🇸 Dallas, Texas, United States