INV-102 for Diabetic Macular Edema

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Invirsa, Inc.

Disqualifiers: Prior laser treatment, others

No Placebo Group

Prior Safety Data

Trial Summary

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 \[Part 1\].

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.

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.

See 1 more

Exclusion Criteria

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

I have diabetic macular edema in my study eye.

Trial 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 (Anti-inflammatory)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Group I: Part 2: INV-102 0.7% in CIDMEExperimental Treatment1 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 NCIDMEExperimental Treatment1 Intervention

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