Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2022-07-15
2027-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
UT-DSAEK plus topical ripasudil
This arm will receive UT-DSAEK plus topical ripasudil 0.4%
Topical Ripasudil
To determine the effect of rho-kinase inhibitors on endothelial cell loss
UT-DSAEK plus topical placebo
This arm will receive UT-DSAEK plus topical placebo
Topical Placebo
topical Placebo
DMEK plus topical ripasudil
This arm will receive DMEK plus topical ripasudil 0.4%
Topical Ripasudil
To determine the effect of rho-kinase inhibitors on endothelial cell loss
DMEK plus topical placebo
This arm will receive DMEK plus topical placebo
Topical Placebo
topical Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Topical Ripasudil
To determine the effect of rho-kinase inhibitors on endothelial cell loss
Topical Placebo
topical Placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
* Dysfunctional endothelium from prior graft failure after PKP or EK
* Controlled uveitis (defined as quiet for \> 3 months off of topical steroids with or without systemic immunosuppression) or no uveitis
* Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP \< 5 mmHg) or no glaucoma
* Good candidate for corneal transplantation for either DMEK or UT-DSAEK
* Willingness to participate
* Age greater than 18 years
Exclusion Criteria
* Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
* Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
* Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
* Pregnancy
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Oregon Health and Science University
OTHER
University of California, San Francisco
OTHER
University of California, Davis
OTHER
Case Western Reserve University
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
University of Pennsylvania
OTHER
University of Miami
OTHER
Wills Eye Hospital
UNKNOWN
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jennifer Rose-Nussbaumer
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Rose-Nussbaumer, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University
Palo Alto, California, United States
University of California Davis
Sacramento, California, United States
University of Miami
Palm Beach Gardens, Florida, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20220590-I
Identifier Type: -
Identifier Source: org_study_id