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

NCT06599684 | Completed Phase 2 FDA Drug

• 1 other identifier: INV-102-CS-004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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 \[Part 2\].

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score

  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.

  Day 84 (Part 1) and Day 56 (Part 2)

• Change from baseline in central subfield thickness (Part 2 only)

  Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center.

  Day 56

Secondary Outcomes (4)

• Change from baseline in macular volume

  Day 84 (Part 1) and Day 56 (Part 2)

• Change from baseline in subfield thickness

  Day 84 (Part 1) and Day 56 (Part 2)

• Change from baseline in the retinal thickness at the thickest point of the subfield thickness

  Day 84 (Part 1) and Day 56 (Part 2)

• Change in best corrected visual acuity (BCVA) (Part 2 only)

  Day 56

Study Arms (2)

Part 1: INV-102 0.7% in NCIDME

EXPERIMENTAL

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

Drug: INV-102

Part 2: INV-102 0.7% in CIDME

EXPERIMENTAL

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

Drug: INV-102

Interventions

INV-102 DRUG

0.7% Ophthalmic Solution

Part 1: INV-102 0.7% in NCIDME; Part 2: INV-102 0.7% in CIDME

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior laser treatment for DR in the study eye within 12 months from Screening Visit

Sponsors & Collaborators

• Invirsa, Inc.: lead

Study Sites (1)

MedTrials, Inc.

Dallas, Texas, 75204, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Robert Shalwitz

  Invirsa, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: September 7, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

US (1)