Actively Recruiting
Phase 1 Open-Label Study of EO2002 Intracameral Injections With or Without Topical Ripasudil for Corneal Edema
Led by Asociación para Evitar la Ceguera en México · Updated on 2025-12-08
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Asociación para Evitar la Ceguera en México
Lead Sponsor
E
Emmecell
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of multiple doses of EO2002, a treatment involving intracameral injections of magnetic human corneal endothelial cells, for people with corneal edema caused by endothelial dysfunction such as Fuchs' dystrophy or pseudophakic bullous keratopathy. This open-label Phase 1 study is sponsored by the Asociación para Evitar la Ceguera en México and aims to understand how EO2002 works with or without the addition of topical Ripasudil drops. Participants receive EO2002 injections either with daily topical Ripasudil followed by a reinjection at week 6 and continued Ripasudil use, or EO2002 injections at Day 0 and Week 6 without Ripasudil. The study is non-randomized and involves close monitoring over a 32-week period to assess safety and tolerability of these treatments. Throughout the study, participants will undergo assessments of central corneal thickness and best corrected visual acuity to evaluate eye health and function. Safety will be carefully monitored during the 32 weeks of treatment. Participants should expect regular visits for injections, eye exams, and vision testing as part of their involvement in the study.
CONDITIONS
Brief Title
Study to Assess Safety and Tolerability of Multiple Doses of EO2002
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Phakic or pseudophakic with a posterior chamber intraocular lens
- Symptomatic corneal edema associated with endothelial dysfunction, possibly due to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy
You will not qualify if you...
- Presence of other corneal diseases
- Use of anterior chamber intraocular lens
- Sutured or scleral-fixated intraocular lens
- Macular disease limiting vision improvement
- History of refractive surgery
- History of vitrectomy
- Descemet membrane detachment
- History of uveitis or ocular inflammatory disease
- History of incisional glaucoma surgery
- Intraocular pressure greater than 21 or less than 7 mm Hg
- Prior incisional eye surgery within 3 months or corneal transplant
- History of ocular neoplasm
- Fellow eye vision worse than 20/200
- Female who is pregnant, nursing, or not using reliable contraception if of childbearing potential
- Participation in another clinical trial within past 3 months
- Any medical or psychological condition interfering with study participation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 32 weeks
Participants receive intracameral injections of EO2002 with or without daily topical Ripasudil. A reinjection occurs at Week 6 with continued use of Ripasudil if applicable.
Multiple visits including initial injection at Day 0 and reinjection at Week 6 with follow-up visits through Week 32
Trial Site Locations
Total: 1 location
1
Asociacion para Evitar la Ceguera en Mexico
Mexico City, Mexico City, Mexico, 04030
Actively Recruiting
Research Team
Y
Yara Luna
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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