Assessing the safety of EO2002 injections for corneal conditions

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

This study is testing if EO2002 injections are safe for people with corneal conditions like Fuchs' dystrophy or pseudophakic bullous keratopathy.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Asociación para Evitar la Ceguera en México (other)
• Locations: 1 site (Mexico City, Mexico City)
• Trial ID: NCT05636579 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and tolerability of multiple intracameral injections of EO2002, both with and without the addition of topical Ripasudil, in patients suffering from corneal edema and related conditions. The study focuses on individuals who are symptomatic due to endothelial dysfunction, particularly those with Fuchs' corneal dystrophy or pseudophakic bullous keratopathy. Participants will be monitored for any adverse effects and overall safety of the treatment regimen.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic corneal edema due to endothelial dysfunction.

Not a fit: Patients with other corneal diseases or those who have had specific ocular surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with corneal endothelial dysfunction, potentially improving their vision and quality of life.

How similar studies have performed: While this approach is novel, similar studies targeting corneal endothelial dysfunction have shown promise in the past.

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.

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

Conditions: Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Bullous Keratopathy, Pseudophakic Bullous Keratopathy, Corneal Edema Pseudophakic