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Anti-inflammatory

INV-102 for Diabetic Macular Edema

Phase 2
Recruiting
Research Sponsored by Invirsa, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Study eye must have non-center involved diabetic macular edema (NCIDME)
Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0%
Must not have
Prior laser treatment for diabetic retinopathy (DR) in the study eye
Presence of any center involved diabetic macular edema (DME) in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84
Awards & highlights

Summary

This trial is testing whether using eye drops called INV-102 for 12 weeks can help people with a specific type of eye disease called non-center involved diabetic macular edema (NCIDME)

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of INV-102 are not detailed here but may include typical eye drop reactions such as temporary discomfort, watering eyes, redness, or blurred vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eye condition is due to diabetes but does not affect the center of my retina.
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I have diabetes with an A1c level of 12.0% or less.
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My eye condition is severe due to diabetes but not yet proliferative.
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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had laser treatment for diabetic retinopathy in one eye.
Select...
I have diabetic macular edema in my study eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 84
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in the Diabetic Retinopathy Severity Scale (DRSS) score
Secondary study objectives
Change from baseline in macular volume
Change from baseline in subfield thickness
Change from baseline in the retinal thickness at the thickest point of the subfield thickness
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: INV-102 0.7%Experimental Treatment1 Intervention
INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for the reminder of the study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INV-102
2022
Completed Phase 2
~200

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Who is running the clinical trial?

Invirsa, Inc.Lead Sponsor
3 Previous Clinical Trials
295 Total Patients Enrolled
Robert ShalwitzStudy ChairInvirsa, Inc.
~16 spots leftby Mar 2025
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