Descemet Endothelial Thickness Comparison Trial II

Fuchs' Endothelial Dystrophy Clinical Trial

— DETECT II  

Official title:

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275972
• Other study ID #: 20220590-II
• Status: Recruiting
• Phase: Phase 3
• Start date: January 23, 2023
• Est. completion date: November 30, 2027

Study information

• Verified date: May 2024
• Source: Stanford University
• Contact: Nicole Varnado, MPH
• Phone: 650-725-1688
• Email: nvarnado[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 30, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fuchs
• Fuchs Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• Ripasudil
Topical Ripasudil 0.4%
• Placebo
Topical Placebo

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Miami	Palm Beach Gardens	Florida
United States	Stanford University	Palo Alto	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	University of California Davis	Sacramento	California

Sponsors (7)

Lead Sponsor	Collaborator
Stanford University	Case Western Reserve University, Dartmouth-Hitchcock Medical Center, Oregon Health and Science University, University of California, Davis, University of California, San Francisco, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best spectacle-corrected visual acuity (BSCVA)	Best spectacle-corrected visual acuity (BSCVA)	12 months
Secondary	Best spectacle-corrected visual acuity (BSCVA)	Best spectacle-corrected visual acuity (BSCVA)	3, 6 and 24 months
Secondary	Endothelial cell density	Endothelial cell density	3, 6, and 24 months