Descemet Endothelial Thickness Comparison Trial II (DETECT II)

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Descemet Endothelial Thickness Comparison Trial (DETECT) II is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 60 patients with Fuchs endothelial dystrophy to DMEK versus Descemet Stripping Only (DSO) with adjunctive Ripasudil.

Study Overview

• Status: Recruiting
• Conditions: Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Fuchs
• Intervention / Treatment: Drug: Placebo; Drug: Ripasudil

• Study Type: Interventional
• Enrollment (Estimated): 60
• 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 FECD with few guttata extending beyond 4.5 mm
• Peripheral endothelial cell count >1500 cells/mm2
• Good surgical candidate for either procedure as determined by the surgeon
• 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:

• Other primary endothelial dysfunction such as PPMD
• Any prior intraocular surgery other than cataract surgery
• Cataract surgery within the last 3 months
• >3 clock hours of ANY anterior or posterior synechiae
• >1 quadrant of stromal corneal vascularization
• Visually significant optic nerve or macular pathology
• Fellow eye visual acuity <20/200
• Pregnancy
• Inability to comply with post-operative instructions (i.e. unable to position)
• Hypotony (Intraocular pressure <10mmHg)
• Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
• Aphakia, 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: DMEK plus topical placebo	Drug: Placebo; Topical Placebo
Experimental: DSO plus topical ripasudil 0.4%	Drug: Ripasudil; Topical Ripasudil 0.4%

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 (BSCVA)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best spectacle-corrected visual acuity (BSCVA)	Best spectacle-corrected visual acuity (BSCVA)	3, 6 and 24 months
Endothelial cell density	Endothelial cell density	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): January 23, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: March 2, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 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

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 20220590-II

Drug and device information, study documents

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