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Descemet Endothelial Thickness Comparison Trial II (DETECT II)

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ClinicalTrials.gov Identifier: NCT05275972
Recruitment Status : Recruiting
First Posted : March 11, 2022
Last Update Posted : May 10, 2024
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

Study Description
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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
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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)
Actual Study Start Date : January 23, 2023
Estimated Primary Completion Date : November 30, 2026
Estimated Study Completion Date : November 30, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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


Eligibility Criteria
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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/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
Contacts and Locations
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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 650-725-1688 nvarnado@stanford.edu
Contact: Maalika Kanchugantla, MPH maalikaa@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94303
Contact: Nicole Varnado, MPH       nvarnado@stanford.edu   
Principal Investigator: Jennifer Rose-Nussbaumer, MD         
Sub-Investigator: Charles Lin, MD         
University of California Davis Recruiting
Sacramento, California, United States, 95817
Contact: Denise Macias    916-734-6303    dcmacias@ucdavis.edu   
Principal Investigator: Jennifer Li, MD         
United States, Florida
University of Miami Not yet recruiting
Palm Beach Gardens, Florida, United States, 33418
Contact: Ryan Stanfield       rxs421@med.miami.edu   
Principal Investigator: Ellen Koo, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03766
Contact: Katherine Fearon       Katherine.H.Fearon@hitchcock.org   
Principal Investigator: William Gensheimer, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kenia Chavez    503-494-3475    chavezke@ohsu.edu   
Principal Investigator: Winston Chamberlain, MD         
Sub-Investigator: Afshan Nanji, MD         
Sub-Investigator: Richard Stutzman, MD         
Sub-Investigator: Travis Redd, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vincent Lin       Vincent.Lin@Pennmedicine.upenn.edu   
Principal Investigator: Bennie Jeng, MD         
Sub-Investigator: Parveen Nagra, MD         
Wills Eye Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Kieran Alessi       kalessi@willseye.org   
Principal Investigator: Zeba Syed, MD         
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
More Information
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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: May 10, 2024
Last Verified: May 2024

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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