Study of Safety and Tolerability of EO2002 in the Treatment of Corneal Edema
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ClinicalTrials.gov Identifier: NCT04894110 |
Recruitment Status :
Active, not recruiting
First Posted : May 20, 2021
Last Update Posted : May 1, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Corneal Edema Corneal Endothelial Dysfunction Corneal Endothelial Dystrophy Fuchs Dystrophy Fuchs Endothelial Corneal Dystrophy Pseudophakic Bullous Keratopathy Bullous Keratopathy Endothelial Dysfunction Moderate Corneal Endothelial Decompensation | Biological: EO2002 Biological: EO2002 low dose Biological: EO2002 mid dose Biological: EO2002 high dose | Phase 1 |
The study is designed to occur in 2 groups. The objective with the first group is to preliminarily evaluate the safety of 4 escalating doses. The purpose of the second group is to gather additional safety information on the 3 highest doses when administered according to a randomized schedule and evaluated by masked observers.
Group 1: Phase 1 prospective, multi-center, open-label, dose-escalation study designed to evaluate the safety and tolerability of EO2002 with and without endothelial brushing (EB) or Descemet Stripping (DS) in eyes with corneal edema secondary to corneal endothelial dysfunction that qualify for surgery involving full-thickness corneal transplantation or EK. Four doses will be studied in approximately 21 study participants that meet the inclusion/exclusion criteria. Safety and tolerability will be the primary focus for 26 weeks following treatment with EO2002.
Group 2: The three highest doses will be administered to up to 21 subjects in a randomized, double-masked design.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Intervention Model Description: | Group 1: Open-Label, Dose-Escalation Study Group 2: Randomized, double masked |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1, Prospective, Multi-Center, Open-Label, Dose-Escalation Study to Assess the Safety, and Tolerability of EO2002 With and Without Endothelial Brushing or Descemet Stripping in the Treatment of Corneal Edema (EMME-001) |
Actual Study Start Date : | June 22, 2021 |
Estimated Primary Completion Date : | October 30, 2024 |
Estimated Study Completion Date : | October 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: EO2002 treatment - Group 1 |
Biological: EO2002
EO2002 (magnetic human corneal endothelial cells [HCECs]) with and without endothelial brushing (EB) or Descemet Stripping (DS) |
Active Comparator: EO2002 treatment - Group 2 - low dose |
Biological: EO2002 low dose
Low dose of EO2002 (magnetic human corneal endothelial cells) |
Active Comparator: EO2002 treatment - Group 2 - mid dose |
Biological: EO2002 mid dose
Mid dose of EO2002 (magnetic human corneal endothelial cells) |
Active Comparator: EO2002 treatment - Group 2 - high dose |
Biological: EO2002 high dose
High dose of EO2002 (magnetic human corneal endothelial cells) |
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of EO2002] [ Time Frame: 26 Weeks ]Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability of EO2002 (+/- EB or Descemet Stripping)] in subjects with corneal edema at week 26.
- Effect of EO2002 (+/-EB or DS) on corneal thickness [ Time Frame: 26 Weeks ]Evaluate the effect of a single injection of EO2002 (+/-EB or DS) on corneal thickness as determined by pachymetry
- Effect of EO2002 (+/-EB or DS) on best corrected visual acuity (BCVA). [ Time Frame: 26 Weeks ]Evaluate the effect of a single injection of EO2002 (+/-EB or DS) on best corrected visual acuity (BCVA) as determined by ETDRS letter score.
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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All ocular criteria apply to study eye unless otherwise noted.
- Age ≥ 21 years.
- Phakic or Pseudophakic with a posterior chamber intraocular lens
- 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 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.
- Descemet membrane detachment.
- History of uveitis or other ocular inflammatory disease.
- History of incisional glaucoma surgery (e.g.,trabeculectomy, glaucoma drainage implant).
- Intraocular pressure >21 or <7 mm Hg
- Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
- History of ocular neoplasm.
- ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894110
United States, California | |
Los Angeles Location | |
Los Angeles, California, United States, 91208 | |
San Diego Location | |
San Diego, California, United States, 92122 | |
United States, Florida | |
Miami Location | |
Miami, Florida, United States, 33136 | |
Palm Beach Gardens Location | |
Palm Beach Gardens, Florida, United States, 33410 | |
United States, Georgia | |
Atlanta Location | |
Atlanta, Georgia, United States, 30339 | |
United States, Iowa | |
Des Moines Location | |
Des Moines, Iowa, United States, 50266 | |
United States, Kansas | |
Kansas City Location | |
Overland Park, Kansas, United States, 66204 | |
United States, Michigan | |
Grand Rapids Location | |
Grand Rapids, Michigan, United States, 49546 |
Study Director: | Noelia Kunzevitzky | Emmecell |
Responsible Party: | Emmecell |
ClinicalTrials.gov Identifier: | NCT04894110 |
Other Study ID Numbers: |
EMME-001 |
First Posted: | May 20, 2021 Key Record Dates |
Last Update Posted: | May 1, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Corneal Dystrophies, Hereditary Corneal Edema Fuchs' Endothelial Dystrophy Edema |
Corneal Diseases Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn |