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

Description

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, 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 Overview

Study Details

Study overview

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 \[Part 2\].

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)

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

Condition
Non-center Involved Diabetic Macular Edema
Intervention / Treatment

-

Contacts and Locations

Dallas

MedTrials, Inc., Dallas, Texas, United States, 75204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Invirsa, Inc.,

Robert Shalwitz, STUDY_CHAIR, Invirsa, Inc.

Study Record Dates

2025-08