Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
Who is this study for? Patients with Fuchs endothelial dystrophy
What treatments are being studied? Ripasudil
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
• Peripheral endothelial cell count \>1000 cells/mm2 in at least one quadrant
• Good surgical candidate for either procedure as determined by the surgeon
• Willingness to participate
• Age greater than 18 years
Locations
United States
California
Stanford University
RECRUITING
Palo Alto
University of California Davis
RECRUITING
Sacramento
Florida
University of Miami
RECRUITING
Palm Beach Gardens
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Wills Eye Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Nicole Varnado, MPH
nvarnado@stanford.edu
650-725-1688
Backup
Maalika Kanchugantla, MPH
maalikaa@stanford.edu
Time Frame
Start Date: 2023-01-23
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 60
Treatments
Placebo_comparator: DMEK plus topical placebo
Experimental: DSO plus topical ripasudil 0.4%
Related Therapeutic Areas
Sponsors
Leads: Stanford University
Collaborators: University of Miami, Wills Eye Hospital, Oregon Health and Science University, Dartmouth-Hitchcock Medical Center, Case Western Reserve University, University of California, Davis, University of California, San Francisco, University of Pennsylvania