Study to Assess Safety and Tolerability of Multiple Doses of EO2002
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EO2002, Ripasudil.
- Who it may be relevant to
- Registry conditions: Corneal Edema, Corneal Endothelial Dystrophy, Endothelial Dysfunction, Fuchs Dystrophy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.
Interventions
- Biological EO2002
Intracameral injection of magnetic human corneal endothelial cells (EO2002) - Drug Ripasudil
Daily use of Ripasudil drops
Primary outcome measures
- Safety and Tolerability of multiple doses of EO2002 [Time frame: 32 weeks]
Secondary outcome measures (2)
- Central Corneal Thickness [Time frame: 32 weeks]
- Best Corrected Visual Acuity [Time frame: 32 weeks]
Eligibility criteria
Inclusion criteria
All ocular criteria apply to the study eye unless otherwise noted.
- Age ≥ 18 years.
- Subject is phakic or pseudophakic with a posterior chamber intraocular lens (lens in the bag or sulcus).
- Symptomatic corneal edema associated with endothelial dysfunction which may be secondary to Fuchs' corneal dystrophy or pseudophakic bullous keratopathy.
Exclusion criteria
All ocular criteria apply to the study eye unless otherwise noted.
- Other corneal disease
- Anterior chamber intraocular lens
- Sutured or scleral-fixated intraocular lens.
- Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
- History of refractive surgery.
- History of Vitrectomy
- Descemet membrane detachment.
- History of uveitis or other ocular inflammatory disease.
- History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
- IOP >21 or <7 mm Hg
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Asociacion para Evitar la Ceguera en Mexico — Mexico City
Identifiers
NCT: NCT05636579 · VSH-003