Recruiting
Phase 3

DMEK & DSO

Sponsor:

Stanford University

Code:

NCT05275972

Conditions

Fuchs

Fuchs Dystrophy

Fuchs' Endothelial Dystrophy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ripasudil

Placebo

Study Details

Brief 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.

Conditions

Fuchs

Fuchs Dystrophy

Fuchs' Endothelial Dystrophy

Study ID

NCT05275972

Start date

Jan 23, 2023

Status verified date

Aug, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Other primary endothelial dysfunction such as PPMD
  • Visually significant optic nerve or macular pathology
  • Hypotony (Intraocular pressure <10mmHg)
  • Any prior intraocular surgery other than cataract surgery
  • >3 clock hours of ANY anterior or posterior synechiae
  • >1 quadrant of stromal corneal vascularization
  • Inability to comply with post-operative instructions (i.e. unable to position)
  • Pregnancy

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: DMEK plus topical placebo

experimental: DSO plus topical ripasudil 0.4%

Interventions

Ripasudil

Topical Ripasudil 0.4%

Placebo

Topical Placebo

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nicole Varnado, MPH

650-725-1688nvarnado@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94303

Contacts

Nicole Varnado, MPH

nvarnado@stanford.edu

Principal Investigator:

Jennifer Rose-Nussbaumer, MD

University of California Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Denise Macias

916-734-6303dcmacias@ucdavis.edu

Principal Investigator:

Mathew Margolis, MD

University of Miami

Recruiting

Palm Beach Gardens, Florida, United States, 33418

Contacts

Ryan Stanfield

rxs421@med.miami.edu

Principal Investigator:

Ellen Koo, MD

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03766

Contacts

Patrick Herrin

Patrick.R.Herrin@hitchcock.org

Principal Investigator:

William Gensheimer, MD

Legacy Devers Eye Institute

Recruiting

Portland, Oregon, United States, 97210

Contacts

Megan Straiko, PhD

503-413-8377MESTRAIK@LHS.ORG

Principal Investigator:

Michael Straiko, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Kenia Chavez

503-494-3475chavezke@ohsu.edu

Principal Investigator:

Roma Pegany, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Emma Iacobucci

Emma.Iacobucci@Pennmedicine.upenn.edu

Principal Investigator:

Bennie Jeng, MD

Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Alice Drew

adrew@willseye.org

Principal Investigator:

Zeba Syed, MD

More Information

Sponsor

Stanford University

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-17.