Clinical trial NCT05636579: Study to Assess Safety and Tolerability of Multiple Doses of EO2002
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Corneal Edema
Corneal Endothelial Dystrophy
Endothelial Dysfunction
Fuchs Dystrophy
Fuchs' Endothelial Dystrophy
Bullous Keratopathy
Pseudophakic Bullous Keratopathy
Corneal Edema Pseudophakic
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
Collaborators: name: Emmecell
First posted: 2022-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical study is to assess the safety of multiple intracameral injections of EO2002 with and without topical Ripasudil.


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.

Primary outcomes:
measure: Safety and Tolerability of multiple doses of EO2002
timeFrame: 32 weeks
Secondary outcomes:
measure: Central Corneal Thickness
timeFrame: 32 weeks
measure: Best Corrected Visual Acuity
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Asociacion para Evitar la Ceguera en Mexico
state: Cdmx
Study officials:
affiliation: Asociacion para Evitar la Ceguera
name: Valeria Sanchez Huerta, MD
role: PRINCIPAL_INVESTIGATOR
References: