Phase 1, Multiple Dose, Open-Label Study to Assess the Safety and Tolerability of EO2002 Intracameral Injections With or Without Topical Ripasudil in the Treatment of Corneal Edema
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ All ocular criteria apply to the study eye unless otherwise noted.
• Age ≥ 18 years.
• Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
• Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.
Locations
Other Locations
Mexico
Asociacion para Evitar la Ceguera en Mexico
RECRUITING
Mexico City
Contact Information
Primary
Yara Luna
reclutamiento.proyectos@apec.com.mx
55 39 53 12 25
Time Frame
Start Date: 2022-11-08
Estimated Completion Date: 2025-12-09
Participants
Target number of participants: 12
Treatments
Experimental: EO2002 with Ripasudil
EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily
Experimental: EO2002 without Ripasudil
EO2002 injection at Day 0 and re-injection at Week 6
Related Therapeutic Areas
Sponsors
Collaborators: Emmecell
Leads: Asociación para Evitar la Ceguera en México