Descemet Endothelial Thickness Comparison Trial I

Phase 3

Recruiting

• Conditions: Fuchs
• Interventions: Drug: Topical Placebo; Drug: Topical Ripasudil

• Registration Number: NCT05289661
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-15
• Study First Posted: 2022-03-21
• Study Start: 2022-07-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2026-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• 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 dysfuction 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 and ability to undergo corneal transplantation
• Willingness to consistently use study medications (i.e. ROCK-inhibitors)
• Willingness to participate in follow-up visits
• Age greater than 18 years

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Exclusion Criteria

• 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
• Inability to comply with post-operative instructions (i.e. unable to position)
• Pregnancy
• Cataract surgery within the last 3 months
• Fellow eye visual acuity <20/200

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
UT-DSAEK plus topical placebo	Topical Placebo	This arm will receive UT-DSAEK plus topical placebo
DMEK plus topical ripasudil	Topical Ripasudil	This arm will receive DMEK plus topical ripasudil 0.4%
DMEK plus topical placebo	Topical Placebo	This arm will receive DMEK plus topical placebo
UT-DSAEK plus topical ripasudil	Topical Ripasudil	This arm will receive UT-DSAEK plus topical ripasudil 0.4%

Primary Outcome Measures

Name	Time	Method
Best spectacle-corrected visual acuity (BSCVA)	12 months	Best spectacle-corrected visual acuity
Endothelial cell loss	12 months	Change between endothelial density at baseline versus density at 12 months

Secondary Outcome Measures

Name	Time	Method
Best spectacle-corrected visual acuity (BSCVA)	3, 6 and 24 months	Best spectacle-corrected visual acuity

Trial Locations

Locations (7)

University of California Davis; 🇺🇸 Sacramento, California, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, 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

Stanford University; 🇺🇸 Palo Alto, California, United States