DETECT II: Descemet Endothelial Thickness Comparison Trial II

Sponsor

Stanford University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05275972

Collaborator

Oregon Health and Science University (Other), University of California, San Francisco (Other), University of California, Davis (Other), Case Western Reserve University (Other), Dartmouth-Hitchcock Medical Center (Other), University of Pennsylvania (Other)

Enrollment

Locations

Arms

53.6

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fuchs Fuchs Dystrophy Fuchs' Endothelial Dystrophy	Drug: Ripasudil Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Descemet Endothelial Thickness Comparison Trials (DETECT I & II)

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Feb 28, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: DMEK plus topical placebo	Drug: Placebo Topical Placebo
Experimental: DSO plus topical ripasudil 0.4%	Drug: Ripasudil Topical Ripasudil 0.4%

Arm

Intervention/Treatment

Placebo Comparator: DMEK plus topical placebo

Drug: Placebo

Topical Placebo

Experimental: DSO plus topical ripasudil 0.4%

Drug: Ripasudil

Topical Ripasudil 0.4%

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Best spectacle-corrected visual acuity (BSCVA) [3, 6 and 24 months]
Best spectacle-corrected visual acuity (BSCVA)
Endothelial cell density [3, 6, and 24 months]
Endothelial cell density

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94303
2	University of California Davis	Sacramento	California	United States	95817
3	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire	United States	03766
4	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Stanford University
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

Investigators

Principal Investigator: Jennifer Rose-Nussbaumer, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Rose-Nussbaumer, Associate Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT05275972

Other Study ID Numbers:

20220590-II

First Posted:

Mar 11, 2022

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Aug 24, 2022