Assessing the safety of EO2002 injections for corneal conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: reclutamiento.proyectos@apec.com.mx
• Phone: 55 39 53 12 25

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• EO2002 therapy for corneal edema due to endothelial dysfunction

  This trial tests whether a single intracameral injection of EO2002 cells can improve vision and reduce corneal thickness in adults with corneal edema from endothelial dysfunction.

  Recruiting Phase 2 Emmecell · Torrance, California and 9 other locations · NCT07729137

• PVEK corneal implant to treat corneal swelling

  This study will test a PVEK tissue‑engineered corneal implant to see if it is safe and helps people with corneal swelling from Fuchs' endothelial dystrophy or pseudophakic bullous keratopathy who need endothelial keratoplasty.

  Recruiting Phase 1 Precise Bio · Yerevan and 2 other locations · NCT07325097

• Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction

  A one-time cell-injection treatment using non-cultured human corneal endothelial cells is being tested to help adults with corneal endothelial problems like bullous keratopathy see if it is safe and helps vision.

  Recruiting Phase 1 Singapore Eye Research Institute · Hyderabad, Telangana · NCT07711561

• Understanding Fuchs' Endothelial Corneal Dystrophy and its Genetic Links

  This study is trying to understand how Fuchs' Endothelial Corneal Dystrophy affects younger people with a genetic link to the condition by using advanced imaging to track changes over time.

  Recruiting University College, London · London · NCT06881771

• Using plasma rich in growth factors during corneal transplants

  This study tests if using plasma rich in growth factors during corneal transplants can help patients keep more healthy cells after surgery compared to standard methods.

  Recruiting at 2 sites University of Miami · Miami, Florida and 1 other locations · NCT06261346

• OPTIMISE — safer steroid plans after DMEK cornea transplant

  This study tests whether using a milder steroid eye drop plan or stopping steroids earlier after DMEK can still prevent graft rejection while reducing the risk of high eye pressure in adults receiving corneal transplants.

  Recruiting at 6 sites Phase 4 Maastricht University Medical Center · Apeldoorn, Gelderland and 7 other locations · NCT05716945

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.