Study to Assess Safety and Tolerability of Multiple Doses of EO2002

Launched by ASOCIACIÓN PARA EVITAR LA CEGUERA EN MÉXICO · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a new treatment called EO2002 for patients suffering from various corneal conditions, such as corneal edema and Fuchs' dystrophy, which can cause vision problems. The study involves giving participants multiple injections of EO2002 directly into the eye, with some also receiving a topical medication called Ripasudil. The aim is to see how well these treatments work and if they are safe for individuals who have these specific eye issues.

To participate in this study, you need to be at least 18 years old and have certain eye conditions that result in symptoms like swelling in the cornea. However, there are some criteria that could prevent you from joining, such as having other eye diseases, recent eye surgeries, or specific health conditions. If you qualify and choose to participate, you can expect to receive the injections as part of the study, and your health will be closely monitored throughout the process. Remember, this research is important for finding new ways to help improve vision for people with these eye disorders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All ocular criteria apply to the study eye unless otherwise noted.
• • 1. Age ≥ 18 years.
• • 2. Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
• • 3. Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.
• Key Exclusion Criteria:
• • All ocular criteria apply to the study eye unless otherwise noted.
• • 1. Other corneal disease
• • 2. Anterior chamber intraocular lens
• • 3. Sutured or scleral-fixated intraocular lens.
• • 4. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
• • 5. History of refractive surgery.
• • 6. History of Vitrectomy
• • 7. Descemet membrane detachment.
• • 8. History of uveitis or other ocular inflammatory disease.
• • 9. History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
• • 10. IOP \>21 or \<7 mm Hg
• • 11. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
• • 11. History of ocular neoplasm. 12. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
• • 13. 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.
• • 14. 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.
• • 15. 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.

Trial Officials