Health TrialsbyHealthPanel

Study to Assess Safety and Tolerability of Multiple Doses of EO2002

ConditionsCorneal EdemaCorneal Endothelial DystrophyEndothelial DysfunctionFuchs DystrophyFuchs' Endothelial DystrophyBullous KeratopathyPseudophakic Bullous KeratopathyCorneal Edema Pseudophakic
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsociación para Evitar la Ceguera en México

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • EO2002

    Biological/Vaccine

    Intracameral injection of magnetic human corneal endothelial cells (EO2002)

  • Ripasudil

    Drug

    Daily use of Ripasudil drops

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: EO2002 with RipasudilExperimental treatment 2 interventions
Group B: EO2002 without RipasudilExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability of multiple doses of EO2002

Incidence of Treatment-Emergent Adverse Events

Time frame
32 weeks

Secondary outcomes

1

Central Corneal Thickness

Changes in CCT compared to baseline

Time frame
32 weeks
2

Best Corrected Visual Acuity

Changes in BCVA compared to baseline

Time frame
32 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asociación para Evitar la Ceguera en México

Lead sponsor

Emmecell

Collaborator

Source ClinicalTrials.gov
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