NCT05275972

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
31mo left

Started Jan 2023

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jan 2023Nov 2028

First Submitted

Initial submission to the registry

March 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

4.9 years

First QC Date

March 2, 2022

Last Update Submit

December 16, 2025

Conditions

FuchsFuchs DystrophyFuchs' Endothelial Dystrophy

Outcome Measures

Primary Outcomes (1)

  • Best spectacle-corrected visual acuity (BSCVA)

    Best spectacle-corrected visual acuity (BSCVA)

    12 months

Secondary Outcomes (2)

  • Best spectacle-corrected visual acuity (BSCVA)

    3, 6 and 24 months

  • Endothelial cell density

    3, 6, and 24 months

Study Arms (2)

DMEK plus topical placebo

PLACEBO COMPARATOR
Drug: Placebo

DSO plus topical ripasudil 0.4%

EXPERIMENTAL
Drug: Ripasudil

Interventions

RipasudilDRUG

Topical Ripasudil 0.4%

DSO plus topical ripasudil 0.4%
PlaceboDRUG

Topical Placebo

DMEK plus topical placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Stanford University

Palo Alto, California, 94303, United States

RECRUITING

University of California Davis

Sacramento, California, 95817, United States

RECRUITING

University of Miami

Palm Beach Gardens, Florida, 33418, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03766, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (1)

  • Lin CC, Chamberlain W, Benetz BA, Gensheimer W, Li JY, Jeng BH, Clover J, Varnado N, Abdelrahman S, Srinivasan A, Syed ZA, Koo EH, Arnold BF, Lietman TM, Lass J, Rose-Nussbaumer J. Descemet Endothelial Thickness Comparison Trial II (DETECT II): multicentre, outcome assessor-masked, placebo-controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) to Descemet stripping only (DSO) with adjunctive ripasudil for Fuchs dystrophy. BMJ Open Ophthalmol. 2024 Oct 1;9(1):e001725. doi: 10.1136/bmjophth-2024-001725.

    PMID: 39353677DERIVED

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

K-115

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jennifer Rose-Nussbaumer, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Varnado, MPH

CONTACT

650-725-1688nvarnado@stanford.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 2, 2022

First Posted

March 11, 2022

Study Start

January 23, 2023

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations

US(7)