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

Launched by INVIRSA, INC. · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new eye drop called INV-102 to see if it can help adults with a specific type of eye condition related to diabetes. The focus is on patients who have non-center involved diabetic macular edema (NCIDME) associated with non-proliferative diabetic retinopathy (NPDR). Essentially, this means they have swelling in the part of the eye that helps with vision, but it’s not affecting the center area. The trial will last for 12 weeks, during which participants will use these eye drops to see if their condition improves.

To be eligible for this study, participants must be between 18 and 75 years old and have diabetes (either type 1 or type 2) with certain blood sugar levels. They must also have the specific eye condition mentioned. However, people with other types of eye problems or those who have had previous laser treatments on their eyes will not be able to join. Those who participate can expect regular check-ups to monitor their eye health and see how well the treatment is working. This trial is currently recruiting participants, and it's an opportunity to contribute to research that could lead to better treatments for diabetic eye conditions.

Gender

ALL

Eligibility criteria

• 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