Descemet endothelial thickness comparison trial (DETECT)

Active Cooperative Agreement Awarded Last action

Award ID
UG1EY030417
Recipient
Awarding agency
Obligated
$22,843,467

Award facts

Assistance listing
93.867 Vision Research
Completion date 93% complete
Originally
Funding
  • $20,555,922.00 Federal
  • $2,287,545.00 Non-federal
Place of performance
Palo Alto, CA 94303, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Although endothelial keratoplasty is one of the most commonly performed transplant surgeries, IT is unknown which technique provides optimal visual acuity outcomes while minimizing endothelial cell loss and complications. Post-operative endothelial cell counts have been shown to correlate with risk of subsequent graft failure, with significant cost to individual patients and society. Topical RHO-kinase inhibitors such as ripasudil 0.4% may play an important role in maintaining endothelial health after keratoplasty. Here we propose the descemet endothelial thickness comparison trial (DETECT), a randomized, outcome- masked, multi-center, four-arm clinical trial with 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 counts after keratoplasty. Patients presenting to oregon health & science university, stanford university, northshore university healthsystem, university of maryland, and to kaiser permanente northern california with endothelial dysfunction who are good candidates for either UT-DSAEK or DMEK will be eligible for inclusion. Participants will be randomized to one of four treatment groups in this 2X2 factorial design study: endothelial keratoplasty UT-DSAEK DMEK adjuvant topical medication ripasudil 0.4% UT-DSAEK + 0.4% ripasudil DMEK + 0.4% ripasudil placebo UT-DSAEK + placebo DMEK + placebo this approach is innovative for a number of reasons including its testing of a novel treatment, ripasudil 0.4%, and the randomization of surgery, which is relatively rare. IT is aligned with the priorities of the NEI, studying new high-resolution imaging techniques such as endothelial cell imaging, anterior-segment optical coherence and pentacam scheimflug imaging, to guide post-operative treatment and as potential surrogate trial endpoints in future trials. This world class team of collaborators have a proven track record for executing large NEI- funded trials in ophthalmology, and are well positioned to answer the two important questions presented in this proposal.

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Subawards

Subrecipient Amount Awarded
Oregon Health & Science University "Dr. Winston Chamberlain will act as clinical performance site PI, attend to study patients, supervise the study coordinators along with overseeing all… $13,200
University Of California, Davis "All patients will be randomized to undergo one of two types of endothelial keratoplasty. All patients will be randomized to receive either topical ripasudil… $8,050
University Of Miami As a clinical trial site, our team will be instrumental in the trial and will enroll subjects towards the trial. As a PI, I will identify suitable subjects as… $5,372
Dartmouth-Hitchcock Clinic Descemet Endothelial Thickness Comparison Trial is an NIH-funded multi-center, outcome-masked clinical trial randomizing patients with endothelial disease to… $5,000
Case Western Reserve University The CIARC is a shared resource of the Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center. The Center is led by… $45,000
The Trustees Of The University Of Pennsylvania experimental conditions. The analysis will encompass multiple modalities, most $5,687
City Of Philadelphia Trustee Under The Will Of James Wills The Wills Eye Hospital DETECT Study Team, led by Dr. Zeba Syed will perform the following activities for the DETECT1 and DETECT2 studies: I.Prior to opening… $5,670
Dartmouth-Hitchcock Clinic Descemet Endothelial Thickness Comparison Trial is an NIH-funded multi-center, outcome-masked clinical trial randomizing patients with endothelial disease to… $10,000
Case Western Reserve University The CIARC is a shared resource of the Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center. The Center is led by… $75,219
Oregon Health & Science University "Dr. Winston Chamberlain will act as clinical performance site PI, attend to study patients, supervise the study coordinators along with overseeing all… $17,549
Dartmouth-Hitchcock Clinic Descemet Endothelial Thickness Comparison Trial is an NIH-funded multi-center, outcome-masked clinical trial randomizing patients with endothelial disease to… $40,288
The Trustees Of The University Of Pennsylvania experimental conditions. The analysis will encompass multiple modalities, most $12,500
University Of California, Davis "All patients will be randomized to undergo one of two types of endothelial keratoplasty. All patients will be randomized to receive either topical ripasudil… $22,699
City Of Philadelphia Trustee Under The Will Of James Wills The Wills Eye Hospital DETECT Study Team, led by Dr. Zeba Syed will perform the following activities for the DETECT1 and DETECT2 studies: I.Prior to opening… $20,935
University Of Miami As a clinical trial site, our team will be instrumental in the trial and will enroll subjects towards the trial. As a PI, I will identify suitable subjects as… $21,165
The Regents Of The University Of California. San Francisco The F.I. Proctor Foundation is an organized research unit within the Department of Ophthalmology at the University of California San Francisco. Under the… $241,200
The Regents Of The University Of California. San Francisco $65,947
University Of Miami As a clinical trial site, our team will be instrumental in the trial and will enroll subjects towards the trial. As a PI, I will identify suitable subjects as… $25,000
University Of California, Davis "All patients will be randomized to undergo one of two types of endothelial keratoplasty. All patients will be randomized to receive either topical ripasudil… $31,022
Oregon Health & Science University Dr. Winston Chamberlain will act as clinical performance site PI, attend to study patients, supervise the study coordinators along with overseeing all patient… $24,378
The Regents Of The University Of California. San Francisco The F.I. Proctor Foundation is an organized research unit within the Department of Ophthalmology at the University of California San Francisco. Under the… $213,264
Case Western Reserve University The CIARC is a shared resource of the Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center. The Center is led by… $78,818
The Trustees Of The University Of Pennsylvania experimental conditions. The analysis will encompass multiple modalities, most $12,500
Dartmouth-Hitchcock Clinic Descemet Endothelial Thickness Comparison Trial is an NIH-funded multi-center, outcome-masked clinical trial randomizing patients with endothelial disease to… $40,288
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Quick answers

Who received award UG1EY030417?

UG1EY030417 was awarded to The Leland Stanford Junior University by National Eye Institute (National Institutes of Health) on April 1, 2021.

How much is award UG1EY030417 worth?

$22,843,467 has been obligated on UG1EY030417: $20,555,922 in federal funding and $2,287,545 in non-federal funding.

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