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OpenTrials
Completed

NCT Number: NCT06599684

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

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].

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Key information

Conditions

Non-center Involved Diabetic Macular Edema Cardiovascular Diseases Center-involved Diabetic Macular Edema Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy Retinal Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MedTrials, Inc.

Dallas, Texas, 75204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INV-102

Drug

0.7% Ophthalmic Solution

Primary outcomes

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

    Time frame: 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.

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

    Time frame: Day 56

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

Secondary outcomes

  1. Change from baseline in macular volume

    Time frame: Day 84 (Part 1) and Day 56 (Part 2)

    Measured using spectral domain optical coherence tomography (SD-OCT)

  2. Change from baseline in subfield thickness

    Time frame: 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

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

    Time frame: Day 84 (Part 1) and Day 56 (Part 2)

    Measured using SD-OCT in each of the regional subfields of the ETDRS grid

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

    Time frame: Day 56

Sponsors and collaborators

Lead sponsor

Invirsa, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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