INV-102 for Diabetic Macular Edema

Overseen By Invirsa Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Invirsa, Inc.

Disqualifiers: Prior laser treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks (NCIDME) / 8 weeks (CIDME)

24 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

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 \[Part 2\].

Research Team

Robert Shalwitz

Principal Investigator

Invirsa, Inc.

Eligibility Criteria

This trial is for adults with a specific eye condition called non-center involved diabetic macular edema (NCIDME), which is related to diabetes and affects the retina. Participants should have this condition without severe progression that requires immediate surgery.

Inclusion Criteria

My eye condition is due to diabetes but does not affect the center of my retina.

My eye condition is severe due to diabetes but not yet proliferative.

I have diabetes with an A1c level of 12.0% or less.

Exclusion Criteria

I have had laser treatment for diabetic retinopathy in one eye.

I have diabetic macular edema in my study eye.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INV-102 Ophthalmic Solution for 12 weeks in NCIDME and 8 weeks in CIDME

12 weeks (NCIDME) / 8 weeks (CIDME)

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• INV-102

Trial Overview The study tests INV-102 eyedrops' effectiveness over 12 weeks in patients with NCIDME associated with non-proliferative diabetic retinopathy, aiming to reduce retinal swelling and improve vision.

Participant Groups

Group I: Part 2: INV-102 0.7% in CIDME Experimental Treatment 1 Intervention

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

Group II: Part 1: INV-102 0.7% in NCIDME Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Invirsa, Inc.

Lead Sponsor

Trials

4

Recruited

310+