INV-102 eyedrops for diabetic macular edema in adults
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)
This study tests whether INV-102 eyedrops can help adults with diabetic macular edema improve their eye health and vision.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Invirsa, Inc. Industry-sponsored |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06599684 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study evaluates the effectiveness of INV-102, a topically administered ophthalmic solution, in adults suffering from diabetic macular edema (DME) associated with non-proliferative diabetic retinopathy (NPDR). The study is divided into two parts: Part 1 focuses on subjects with non-center involved DME over a 12-week period, while Part 2 examines those with center-involved DME over an 8-week period. Participants will be monitored for changes in their condition and overall eye health throughout the treatment duration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with diabetes and moderate to severe non-proliferative diabetic retinopathy.
Not a fit: Patients who have undergone laser treatment for diabetic retinopathy in the study eye within the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve vision and quality of life for patients with diabetic macular edema.
How similar studies have performed: Other studies have shown promise in treating diabetic macular edema with similar approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- MedTrials, Inc. — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Invirsa Call Center
- Email: info@invirsa.com
- Phone: 614-334-1765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.