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Descemet Endothelial Thickness Comparison Trial II (DETECT II)

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ClinicalTrials.gov Identifier: NCT05275972
Recruitment Status : Not yet recruiting
First Posted : March 11, 2022
Last Update Posted : June 16, 2022
Sponsor:
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
Information provided by (Responsible Party):
Jennifer Rose-Nussbaumer, Stanford University

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : February 28, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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%




Primary Outcome Measures :
  1. Best spectacle-corrected visual acuity (BSCVA) [ Time Frame: 12 months ]
    Best spectacle-corrected visual acuity (BSCVA)


Secondary Outcome Measures :
  1. Best spectacle-corrected visual acuity (BSCVA) [ Time Frame: 3, 6 and 24 months ]
    Best spectacle-corrected visual acuity (BSCVA)

  2. Endothelial cell density [ Time Frame: 3, 6, and 24 months ]
    Endothelial cell density



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05275972


Contacts
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Contact: Nicole Varnado, MPH 4802981310 nvarnado@stanford.edu
Contact: Victoria Cavallino, MSPH 16195406557 victoria.cavallino@ucsf.edu

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
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Principal Investigator: Jennifer Rose-Nussbaumer, MD Stanford University
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Responsible Party: Jennifer Rose-Nussbaumer, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT05275972    
Other Study ID Numbers: 20220590-II
First Posted: March 11, 2022    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn