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Descemet Endothelial Thickness Comparison Trial II (DETECT II)

Primary Purpose

Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ripasudil
Placebo
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dysfunctional endothelium from FECD with few guttata extending beyond 4.5 mm
  • Peripheral endothelial cell count >1500 cells/mm^2
  • 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 18years

Exclusion Criteria:

  • Other primary endothelial dysfunction such as PPMD
  • Any prior intraocular surgery other than cataract surgery
  • Cataract surgery within the last 3 months
  • AC IOL or scleral-fixated IOL
  • >3 clock hours of anterior or posterior synechiae
  • >1 quadrant of stromal corneal vascularization
  • Uncontrolled glaucoma (IOP>25)
  • Uncontrolled uveitis
  • Visually significant anterior stromal scarring
  • Visually significant optic nerve or macular pathology
  • Fellow eye visual acuity <20/200
  • Pregnancy
  • Children (18 years and under)

Sites / Locations

  • Stanford UniversityRecruiting
  • University of California DavisRecruiting
  • Dartmouth-Hitchcock Medical CenterRecruiting
  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

DMEK plus topical placebo

DSO plus topical ripasudil 0.4%

Arm Description

Outcomes

Primary Outcome Measures

Best spectacle-corrected visual acuity (BSCVA)
Best spectacle-corrected visual acuity (BSCVA)

Secondary Outcome Measures

Best spectacle-corrected visual acuity (BSCVA)
Best spectacle-corrected visual acuity (BSCVA)
Endothelial cell density
Endothelial cell density

Full Information

First Posted
March 2, 2022
Last Updated
January 30, 2023
Sponsor
Stanford University
Collaborators
Oregon Health and Science University, University of California, San Francisco, University of California, Davis, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05275972
Brief Title
Descemet Endothelial Thickness Comparison Trial II
Acronym
DETECT II
Official Title
Descemet Endothelial Thickness Comparison Trials (DETECT I & II)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Oregon Health and Science University, University of California, San Francisco, University of California, Davis, Case Western Reserve University, Dartmouth-Hitchcock Medical Center, University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs, Fuchs Dystrophy, Fuchs' Endothelial Dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DMEK plus topical placebo
Arm Type
Placebo Comparator
Arm Title
DSO plus topical ripasudil 0.4%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ripasudil
Intervention Description
Topical Ripasudil 0.4%
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical Placebo
Primary Outcome Measure Information:
Title
Best spectacle-corrected visual acuity (BSCVA)
Description
Best spectacle-corrected visual acuity (BSCVA)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Best spectacle-corrected visual acuity (BSCVA)
Description
Best spectacle-corrected visual acuity (BSCVA)
Time Frame
3, 6 and 24 months
Title
Endothelial cell density
Description
Endothelial cell density
Time Frame
3, 6, and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole Varnado, MPH
Phone
4802981310
Email
nvarnado@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Cavallino, MSPH
Phone
16195406557
Email
victoria.cavallino@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Rose-Nussbaumer, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Varnado, MPH
Email
nvarnado@stanford.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Rose-Nussbaumer, MD
First Name & Middle Initial & Last Name & Degree
Charles Lin, MD
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Macias
Phone
916-734-6303
Email
dcmacias@ucdavis.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Li, MD
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Li
Email
Xiao.Y.Li@hitchcock.org
First Name & Middle Initial & Last Name & Degree
William Gensheimer, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenia Chavez
Phone
503-494-3475
Email
chavezke@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Winston Chamberlain, MD

12. IPD Sharing Statement

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Descemet Endothelial Thickness Comparison Trial II

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