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Descemet Endothelial Thickness Comparison Trial I (DETECT I)

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ClinicalTrials.gov Identifier: NCT05289661
Recruitment Status : Not yet recruiting
First Posted : March 21, 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) I is a multi-center, outcome assessor-masked, placebo-controlled clinical trial randomizing 160 patients in a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.

Condition or disease Intervention/treatment Phase
Fuchs Drug: Topical Ripasudil Drug: Topical Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial 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 : September 30, 2025
Estimated Study Completion Date : June 30, 2026

Arm Intervention/treatment
Experimental: UT-DSAEK plus topical ripasudil
This arm will receive UT-DSAEK plus topical ripasudil 0.4%
Drug: Topical Ripasudil
To determine the effect of rho-kinase inhibitors on endothelial cell loss
Other Name: Ripasudil

Placebo Comparator: UT-DSAEK plus topical placebo
This arm will receive UT-DSAEK plus topical placebo
Drug: Topical Placebo
topical Placebo
Other Name: Placebo

Experimental: DMEK plus topical ripasudil
This arm will receive DMEK plus topical ripasudil 0.4%
Drug: Topical Ripasudil
To determine the effect of rho-kinase inhibitors on endothelial cell loss
Other Name: Ripasudil

Placebo Comparator: DMEK plus topical placebo
This arm will receive DMEK plus topical placebo
Drug: Topical Placebo
topical Placebo
Other Name: Placebo




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

  2. Endothelial cell loss [ Time Frame: 12 months ]
    Change between endothelial density at baseline versus density at 12 months


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



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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 Fuchs Endothelial Corneal Dystrophy (FECD) with guttata extending beyond 4.5 mm of the central cornea
  • Dysfunctional endothelium from Pseudophakic Corneal Edema (PCE) or Iridocorneal Endothelial Syndrome (ICE) or other primary endothelial dysfunction such as Posterior Polymorphous Corneal Dystrophy (PPMD)
  • Controlled uveitis (defined as quiet for > 3 months off of topical steroids with or without systemic immunosuppression)
  • Controlled glaucoma with topical medications and/or prior trabeculectomy or tube shunt without ongoing hypotony (IOP < 5 mmHg)
  • Good candidate for corneal transplantation for either DMEK or UT-DSAEK
  • Prior graft failure after PKP or EK
  • 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:

  • Uncontrolled uveitis
  • Aphakia, or anterior chamber 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
  • Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
  • Uncontrolled glaucoma (IOP >25 mmHg)
  • Visually significant optic nerve (ok to have small visual field defects) or macular severe pathology
  • Participants who are not suitable for the DMEK or UT-DSAEK surgeries
  • Indication for surgery that is not suitable for EK (e.g. keratoconus, stromal dystrophies and scars)
  • Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL at time of study EK
  • Hypotony (Intraocular pressure <10mmHg)
  • Inability to comply with post-operative instructions (i.e. unable to position)
  • Participants who are decisionally and/or cognitively impaired
  • Pregnancy
  • Fellow eye visual acuity <20/200
  • 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): NCT05289661


Contacts
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Contact: Nicole Varnado, MPH 4802981310 nvarnado@stanford.edu
Contact: Victoria Cavallino, MSPH 6195406557 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: NCT05289661    
Other Study ID Numbers: 20220590-I
First Posted: March 21, 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