Descemet Endothelial Thickness Comparison Trial II

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05275972
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Fuchs
  • Fuchs Dystrophy
  • Fuchs' Endothelial Dystrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ripasudil — DRUG
    Topical Ripasudil 0.4%
  • Placebo — DRUG
    Topical Placebo

Study Details

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.

Key Dates

Start date
Jan 23, 2023
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: DMEK plus topical placebo
  • Experimental: DSO plus topical ripasudil 0.4%

Primary Outcome Measure

Best spectacle-corrected visual acuity (BSCVA) [ Time Frame: 12 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94303
Nicole Varnado, MPH
[email protected]
Jennifer Rose-Nussbaumer, MD (PRINCIPAL_INVESTIGATOR)
Charles Lin, MD (SUB_INVESTIGATOR)
University of California DavisSacramentoCalifornia95817
Denise Macias
[email protected]
916-734-6303
Mathew Margolis, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiPalm Beach GardensFlorida33418
Ryan Stanfield
[email protected]
Ellen Koo, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03766
Patrick Herrin
[email protected]
William Gensheimer, MD (PRINCIPAL_INVESTIGATOR)
Legacy Devers Eye InstitutePortlandOregon97210
Megan Straiko, PhD
[email protected]
503-413-8377
Michael Straiko, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health & Science UniversityPortlandOregon97239
Kenia Chavez
[email protected]
503-494-3475
Roma Pegany, MD (PRINCIPAL_INVESTIGATOR)
Afshan Nanji, MD (SUB_INVESTIGATOR)
Richard Stutzman, MD (SUB_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Emma Iacobucci
[email protected]
Bennie Jeng, MD (PRINCIPAL_INVESTIGATOR)
Parveen Nagra, MD (SUB_INVESTIGATOR)
Wills Eye HospitalPhiladelphiaPennsylvania19107
Zeba Syed, MD (PRINCIPAL_INVESTIGATOR)

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Stanford University· Palo Alto, CAUniversity of California Davis· Sacramento, CAUniversity of Miami· Palm Beach Gardens, FLDartmouth-Hitchcock Medical Center· Lebanon, NHLegacy Devers Eye Institute· Portland, OROregon Health & Science University· Portland, OR

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