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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-07

Study Completion Date

2025-09-30

Brief Summary

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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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Detailed Description

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Conditions

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: INV-102 0.7% in NCIDME

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

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

0.7% Ophthalmic Solution

Part 2: INV-102 0.7% in CIDME

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

Group Type EXPERIMENTAL

INV-102

Intervention Type DRUG

0.7% Ophthalmic Solution

Interventions

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INV-102

0.7% Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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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