Descemet Endothelial Thickness Comparison Trial I

NCT05289661 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20220590-I
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 7

Brief Summary

Descemet Endothelial Thickness Comparison Trial (DETECT) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.

Conditions

Fuchs

Outcome Measures

Primary Outcomes (2)

• Best spectacle-corrected visual acuity (BSCVA)

  Best spectacle-corrected visual acuity

  12 months

• Endothelial cell loss

  Change between endothelial density at baseline versus density at 12 months

  12 months

Secondary Outcomes (1)

• Best spectacle-corrected visual acuity (BSCVA)

  3, 6 and 24 months

Study Arms (4)

UT-DSAEK plus topical ripasudil

EXPERIMENTAL

This arm will receive UT-DSAEK plus topical ripasudil 0.4%

Drug: Topical Ripasudil

UT-DSAEK plus topical placebo

PLACEBO COMPARATOR

This arm will receive UT-DSAEK plus topical placebo

Drug: Topical Placebo

DMEK plus topical ripasudil

EXPERIMENTAL

This arm will receive DMEK plus topical ripasudil 0.4%

Drug: Topical Ripasudil

DMEK plus topical placebo

PLACEBO COMPARATOR

This arm will receive DMEK plus topical placebo

Drug: Topical Placebo

Interventions

Topical Ripasudil DRUG

To determine the effect of rho-kinase inhibitors on endothelial cell loss

Also known as: Ripasudil

DMEK plus topical ripasudil; UT-DSAEK plus topical ripasudil

Topical Placebo DRUG

topical Placebo

Also known as: Placebo

DMEK plus topical placebo; UT-DSAEK plus topical placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dysfunctional endothelium from Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea or severe edema without visualization of guttata
• 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

You may not qualify if:

• Aphakia, or anterior chamber IOL or scleral fixated IOL in study eye prior to or anticipated during EK
• 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

Sponsors & Collaborators

• University of California, San Francisco: collaborator
• University of California, Davis: collaborator
• Case Western Reserve University: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• University of Pennsylvania: collaborator
• University of Miami: collaborator
• Wills Eye Hospital: collaborator
• Stanford University: lead
• Oregon Health and Science University: collaborator

Study Sites (7)

Stanford University

Palo Alto, California, 94303, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

University of Miami

Palm Beach Gardens, Florida, 33418, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

K-115

Study Officials

• Jennifer Rose-Nussbaumer, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 21, 2022
• Study Start: July 15, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (7)