Descemet Endothelial Thickness Comparison Trial I (DETECT I)

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

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.

Study Overview

• Status: Recruiting
• Conditions: Fuchs
• Intervention / Treatment: Drug: Topical Ripasudil; Drug: Topical Placebo

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nicole Varnado, MPH; Phone Number: 4802981310; Email: nvarnado@stanford.edu
• Study Contact Backup: Name: Maalika Kanchugantla, MPH; Email: maalikaa@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Stanford University
      • Contact: Nicole Varnado, MPH; Email: nvarnado@stanford.edu
      • Principal Investigator: Jennifer Rose-Nussbaumer, MD
      • Sub-Investigator: Charles Lin, MD
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California Davis
      • Principal Investigator: Jennifer Li, MD
      • Contact: Denise Macias; Phone Number: 916-734-6303; Email: dcmacias@ucdavis.edu
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Contact: Xiao Li; Email: Xiao.Y.Li@hitchcock.org
      • Principal Investigator: William Gensheimer, MD
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health & Science University
      • Contact: Kenia Chavez; Phone Number: 503-494-3475; Email: chavezke@ohsu.edu
      • Principal Investigator: Winston Chamberlain, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UT-DSAEK plus topical ripasudil; This arm will receive UT-DSAEK plus topical ripasudil 0.4%	Drug: Topical Ripasudil; To determine the effect of rho-kinase inhibitors on endothelial cell loss; Other Names: Ripasudil
Placebo Comparator: UT-DSAEK plus topical placebo; This arm will receive UT-DSAEK plus topical placebo	Drug: Topical Placebo; topical Placebo; Other Names: Placebo
Experimental: DMEK plus topical ripasudil; This arm will receive DMEK plus topical ripasudil 0.4%	Drug: Topical Ripasudil; To determine the effect of rho-kinase inhibitors on endothelial cell loss; Other Names: Ripasudil
Placebo Comparator: DMEK plus topical placebo; This arm will receive DMEK plus topical placebo	Drug: Topical Placebo; topical Placebo; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best spectacle-corrected visual acuity (BSCVA)	Best spectacle-corrected visual acuity	3, 6 and 24 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of Pennsylvania; University of California, Davis; Oregon Health and Science University; University of California, San Francisco; Dartmouth-Hitchcock Medical Center; Case Western Reserve University
• Investigators: Principal Investigator: Jennifer Rose-Nussbaumer, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 15, 2022
• First Posted (Actual): March 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20220590-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No