Actively Recruiting
Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
Led by Asociación para Evitar la Ceguera en México · Updated on 2025-12-08
32
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 EO2002, a biological treatment consisting of magnetic human corneal endothelial cells, in people who have undergone cataract surgery. This Phase 1 clinical trial focuses on subjects with cataract and decreased endothelial cell count, aiming to understand how EO2002 affects these patients post-surgery. The study is randomized, double-masked, and sham-controlled to carefully assess the treatment's safety profile. Participants will receive a single dose of EO2002 injected into the eye either at the time of cataract surgery or after the surgery. There are multiple study groups including EO2002 given at surgery, EO2002 given after surgery, EO2002 given at or after surgery, and a sham injection group for comparison. The study is designed to closely monitor and compare these different treatment timings. During the study, participants will be followed for 26 weeks to assess safety and tolerability, including changes in endothelial cell density. Various eye examinations and assessments will be conducted regularly to monitor the treatment effects and any side effects. The study aims to provide detailed information on the safety of EO2002 in this patient population over a six-month period.
CONDITIONS
Brief Title
Safety and Tolerability of EO2002
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- History of uncomplicated cataract requiring standard extraction with intraocular lens implant surgery
- Decreased endothelial cell count
You will not qualify if you...
- Presence of other corneal diseases
- Macular disease limiting ability to improve best-corrected visual acuity
- Descemet membrane detachment
- History of uveitis or ocular inflammatory disease
- History of incisional glaucoma surgery
- Eye surgery within 3 months before study treatment or prior keratoplasty
- History of ocular neoplasm
- Best-corrected visual acuity worse than 35 letters in the fellow eye
- Female who is pregnant, nursing, planning pregnancy, or of childbearing potential not using reliable contraception
- Participation in another clinical trial with investigational drug within last 3 months
- Any medical or psychological condition that may interfere with study participation or suitability 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 - Day of surgery
Participants undergo cataract surgery and receive either the EO2002 injection or a sham injection at the time of or shortly after surgery.
1 visit (in-person)
Duration - Up to 26 weeks
Participants are monitored for safety, tolerability, and endothelial cell density following surgery and injection.
Multiple follow-up visits over 26 weeks
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
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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