Safety and Preliminary Efficacy of IVMED-80 Eye Drops in Keratoconus Patients

• Status: Completed
• Trial end date: 2020-07-08
• Target enrollment: 0
• Participant gender: All

Summary

We investigated the use of a copper sulfate eye drop (IVMED-80) for the treatment of keratoconus. Preliminary laboratory data shows that the addition of copper sulfate increase crosslinking of the structural proteins of the cornea thereby halting the progressing corneal thinning and bulging seen in keratoconus. We conducted a Phase 1/2a study to evaluate the safety and preliminary efficacy of a 6-week and a 16-week regimen using IVMED-80 and studied its impact on ocular safety and the change/progression in patients' vision and clinical measurements.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: iVeena Delivery Systems, Inc.
• Collaborator: Codet Vision Institute

Criteria

Inclusion Criteria:

1. Mild to moderate keratoconus and/or corneal ectasia post-LASIK or Photo-Refractive Keratectomy

2. Age 18 to 40

3. Minimum corneal thickness of > 350 microns

4. Maximum corneal keratometry of 45 D to 67 D

5. Absence of systemic comorbidities that pose a significant surgical risk

6. Absence of ocular comorbidities

7. Willing and able to comply with clinic visits and study-related procedures.

8. Provide signed informed consent

Exclusion Criteria:

1. Significant central corneal scarring or hydrops

2. Previous corneal surgeries

3. Presence of pre-existing glaucoma, uveitis, uncontrolled diabetic retinopathy, or prior ocular trauma or prior intraocular surgery.

4. Myopic degeneration with potential acuity less than 20/40 in the Study Eye.

5. Down's Syndrome, retinitis pigmentosa, Ehlers-Danlos Syndrome, osteogenesis imperfecta (or other collagen disorder) or Anton's Syndrome.

6. Prior retinal detachment involving the macula

7. Received a sub-Tenon's injection of corticosteroid within the past 6 months, or any intravitreal injection within the past 6 months in the study eye prior to Visit 1

8. Current use, or anticipated initiation during the study, of a systemic corticosteroid or an immunosuppressant agent by any route (oral, injectables)

9. History or current condition of substance or alcohol abuse within the past year

10. Participation in a clinical trial with use of any investigational drug or treatment within 30 days prior to Visit 1

11. Employee of the study site or their immediate families.

12. Pregnancy or planning to become pregnant.