Assessing the safety of EO2002 after cataract surgery
Phase 1, Randomized, Masked, Sham-Controlled Study to Assess the Safety and Tolerability of EO2002 in Subjects Undergoing Cataract Surgery
This study is testing if a new treatment called EO2002 is safe for people who have just had cataract surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Asociación para Evitar la Ceguera en México Academic / other |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT05587205 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the safety and tolerability of EO2002, administered through an intracameral injection, in patients who have undergone cataract surgery. The trial focuses on individuals with a history of uncomplicated cataracts and decreased endothelial cell counts. Participants will receive either the EO2002 treatment or a sham injection to compare outcomes. The study aims to gather data on the safety profile of EO2002 in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a history of uncomplicated cataracts requiring surgery and decreased endothelial cell counts.
Not a fit: Patients with other corneal diseases, significant macular disease, or recent ocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve recovery and outcomes for patients undergoing cataract surgery.
How similar studies have performed: While this approach is novel in the context of EO2002, similar studies assessing safety in ocular treatments have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Age ≥ 18 years. 2. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery. 3. Decreased endothelial cell count Exclusion Criteria: All ocular criteria apply to study eye unless otherwise noted. 1. Other corneal disease 2. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA. 3. Descemet membrane detachment. 4. History of uveitis or other ocular inflammatory disease. 5. History of incisional glaucoma surgery 6. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty. 7. History of ocular neoplasm. 8. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200). 9. Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study. 10. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration. 11. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.
Where this trial is running
Mexico City, Mexico City
- Asociacion para Evitar la Ceguera en Mexico — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Valeria Sanchez Huerta, MD — Asociacion para Evitar la Ceguera
- Study coordinator: Yara Luna
- Email: reclutamiento.proyectos@apec.com.mx
- Phone: 55 39 53 12 25
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.