Corneal EdemaPhase 1NCT04191629
Phase 1 Study to Evaluate the Safety and Tolerability of EO1404 in the Treatment of Corneal Edema
A Phase 1 study testing EO1404 and Endothelial brushing or Descemet stripping in people with Corneal Edema and Fuchs Dystrophy, run by Valeria Sanchez-Huerta at 1 site in Mexico.
Trial summary
Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Corneal Edema, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy
- What is being tested?
- EO1404 and Endothelial brushing or Descemet stripping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteMexico
- Study dates
- 4 May 2016to 28 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- 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.
- a Symptoms including reduced vision and/or glare, and/or pain; subject may or may not have been on topical therapies such as 5% sodium chloride drops or prednisolone acetate 1% drops.
- b ETDRS-best corrected visual acuity worse than 20/63 on Snellen. c Central corneal thickness < 2 mm by ultrasound pachymetry or OCT. d Subject must have progressed far enough in their clinical course to be considered a surgical candidate for full-thickness corneal transplantation or endothelial keratoplasty.
- Subject must understand and sign the informed consent. If the subject's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the subject in their maternal language.
- Subject must be medically able and willing to undergo the protocol-required procedures.
Who cannot join
- All ocular criteria apply to study eye unless otherwise noted.
- Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
- Visual acuity in the fellow eye is worse than 20/200.
- Anterior chamber intraocular lens.
- Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
- History of vitrectomy.
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- History of refractive surgery.
- Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
- Prior incisional eye surgery within 3 months prior to study treatment.
- Subject is receiving systemic steroids or other systemic immunosuppressive medications.
- 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.
- History of uveitis or other ocular inflammatory disease.
- History of glaucoma, or peripheral anterior synechiae on gonioscopy.
- History of incisional glaucoma surgery (e.g., trabeculectomy, glaucoma drainage implant).
- Female subject 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 immunodeficient, or tested positive for HIV.
- Subject is on chemotherapy.
- History of malignancy other than basal cell carcinoma, UNLESS the malignancy was treated successfully 5 years prior to inclusion in the study.
- History of ocular neoplasm.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Asociación Para Evitar la Ceguera en México, IAP, Hospital "Dr. Luis Sánchez Bulnes"
Mexico City, 04030
Sanchez-Huerta Valeria, MD, 10841400 ext. 1043
Sanchez-Huerta Valeria, MD
About this study
Official title: Phase 1 Clinical Study to Evaluate Safety and Tolerability of Magnetic Human Corneal Endothelial Cells in the Treatment of Corneal Edema
Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy.
- Conditions
- Corneal Edema, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Endothelial Dystrophy, Corneal Transplant Failure
- Being tested
- EO1404, Endothelial brushing or Descemet stripping
- Medical subject headings
- Corneal Edema, Fuchs' Endothelial Dystrophy, Corneal Dystrophy, Posterior Polymorphous, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EO1404Combination product
Also called Magnetic Human Corneal Endothelial Cells
Endothelial brushing or Descemet strippingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 50K to 200K cells | Experimental | Not described Receives: Combination Product: EO1404 |
| 50K to 200K cells with endothelial brushing | Experimental | Not described Receives: Combination Product: EO1404; Procedure: Endothelial brushing or Descemet stripping |
| 500K cells | Experimental | Not described Receives: Combination Product: EO1404 |
| 500K cells with endothelial brushing | Experimental | Not described Receives: Combination Product: EO1404; Procedure: Endothelial brushing or Descemet stripping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Adverse Events
Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure
Measured: 12 months
Secondary outcomes (2)
BVCA
Best corrected visual acuity
Measured: 12 months
Corneal thickness
Decrease in corneal thickness
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start4 May 2016
- Primary completion31 Dec 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valeria Sanchez-Huerta
- Sponsor type
- University, hospital or other
- Collaborators
- Emmecell
- Responsible party
- Sponsor-investigator, Valeria Sanchez-Huerta, Asociación para Evitar la Ceguera en México
- Investigators
- Valeria Sanchez-Huerta, MD, Principal investigator, Asociacion Para Evitar la Ceguera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191629
- Sponsor's protocol ID
- VSH01
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Study to Evaluate Safety and Tolerability of Magnetic Human Corneal Endothelial Cells in the Treatment of Corneal Edema
- ClinicalTrials.gov ID
- NCT04191629
- Acronym / sponsor ID
- VSH01
- Conditions
- Corneal Edema, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Corneal Endothelial Dystrophy, Corneal Transplant Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Valeria Sanchez-HuertaUniversity, hospital or other
- Collaborators
- Emmecell
- Study start
- 4 May 2016 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single center, phase 1 study to evaluate the safety and tolerability of EO1404 in subjects with corneal edema secondary to pseudophakic bullous keratopathy or Fuch's endothelial dystrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50K to 200K cells | Experimental | Combination Product: EO1404 |
| 50K to 200K cells with endothelial brushing | Experimental | Combination Product: EO1404, Procedure: Endothelial brushing or Descemet stripping |
| 500K cells | Experimental | Combination Product: EO1404 |
| 500K cells with endothelial brushing | Experimental | Combination Product: EO1404, Procedure: Endothelial brushing or Descemet stripping |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 21 years
- 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.
- a Symptoms including reduced vision and/or glare, and/or pain; subject may or may not have been on topical therapies such as 5% sodium chloride drops or prednisolone acetate 1% drops.
- b ETDRS-best corrected visual acuity worse than 20/63 on Snellen. c Central corneal thickness < 2 mm by ultrasound pachymetry or OCT. d Subject must have progressed far enough in their clinical course to be considered a surgical candidate for full-thickness corneal transplantation or endothelial keratoplasty.
Key exclusion criteria (19 listed)
- All ocular criteria apply to study eye unless otherwise noted.
- Other corneal disease, including active or prior herpetic ocular infection; active inflammation; corneal scarring from trauma, burns, or infection; or band keratopathy.
- Visual acuity in the fellow eye is worse than 20/200.
- Anterior chamber intraocular lens.
- Subject requires topical, intravenous or oral acyclovir and/or related products during study duration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EO1404Also: Magnetic Human Corneal Endothelial Cells | Combination product | 500K cells, 500K cells with endothelial brushing, 50K to 200K cells, 50K to 200K cells with endothelial brushing |
| Endothelial brushing or Descemet stripping | Procedure or surgery | 500K cells with endothelial brushing, 50K to 200K cells with endothelial brushing |
Primary outcome
Evaluation of Adverse Events
Time frame: 12 months
Evaluation of safety adverse events including worsening of corneal edema and increase in intraocular pressure
2 secondary outcomes
BVCA
Time frame: 12 months
Corneal thickness
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Individual participant dataSharing planned: No
Related trials for Corneal Edema
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Fuchs' Endothelial Dystrophy, Corneal Edema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valeria Sanchez-Huerta, MD principal investigator
Asociacion Para Evitar la Ceguera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EO1404 and Endothelial brushing or Descemet stripping in people with Corneal Edema and Fuchs Dystrophy, run by Valeria Sanchez-Huerta at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valeria Sanchez-Huerta, MD (+5210841400 ext. 1234, valeriash@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.