RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 \[Part 2\].

Official 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)

Quick Facts

Study Start:2024-09-07
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06599684

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female subjects ≥ 18 years of age and \< 76 years of age
  2. * Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0%
  3. * Study eye must have NCIDME (Part 1) or CIDME (Part 2)
  4. * Study eye must be moderate to severe NPDR
  1. * Prior laser treatment for DR in the study eye within 12 months from Screening Visit

Contacts and Locations

Study Contact

Invirsa Call Center
CONTACT
614-334-1765
info@invirsa.com

Principal Investigator

Robert Shalwitz
STUDY_CHAIR
Invirsa, Inc.

Study Locations (Sites)

MedTrials, Inc.
Dallas, Texas, 75204
United States

Collaborators and Investigators

Sponsor: Invirsa, Inc.

  • Robert Shalwitz, STUDY_CHAIR, Invirsa, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-07
Study Completion Date2025-08

Study Record Updates

Study Start Date2024-09-07
Study Completion Date2025-08

Terms related to this study

Additional Relevant MeSH Terms

  • 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