NCT05636579RecruitingPhase 1
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
Asociación para Evitar la Ceguera en México1 site in 1 country12 target enrollmentStarted: November 8, 2022Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability of multiple doses of EO2002
Study Overview
Brief Summary
The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
EO2002 with Ripasudil
Experimental
EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily
Intervention: EO2002 (Biological)
EO2002 with Ripasudil
Experimental
EO2002 + topical Ripasudil daily, then reinjection at week 6 + topical Ripasudil daily
Intervention: Ripasudil (Drug)
EO2002 without Ripasudil
Experimental
EO2002 injection at Day 0 and re-injection at Week 6
Intervention: EO2002 (Biological)
Outcomes
Primary Outcomes
Safety and Tolerability of multiple doses of EO2002
Time Frame: 32 weeks
Incidence of Treatment-Emergent Adverse Events
Secondary Outcomes
- Best Corrected Visual Acuity(32 weeks)
- Central Corneal Thickness(32 weeks)
Investigators
Study Sites (1)
Loading locations...
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