Glaucoma drainage device and endothelial cell density loss compare (declare) trial

Active Cooperative Agreement Awarded Last action

Award ID
UG1EY033703
Recipient
Awarding agency
Obligated
$6,603,824

Award facts

Assistance listing
93.867 Vision Research
Completion date 71% complete
Place of performance
San Francisco, CA 94143, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Glaucoma drainage device (GDD) surgery has gained popularity in managing patients with medically uncontrolled glaucoma. However, one of the major long-term complications of GDD is progressive corneal endothelial cell loss (ECL) leading to corneal decompensation, which requires complex care. Although surgical techniques have been modified to insert the tube into the ciliary sulcus to address this issue, anterior chamber (AC) tube placement remains the preferred location, as there is a lack of convincing data to validate the advantages of sulcus placement. For example, (1) direct comparison of endothelial cell loss (ECL) after sulcus versus AC tube placement is limited to three retrospective studies; (2) studies are inconsistent regarding whether intraocular pressure (IOP) and other surgical outcomes are similar after sulcus tube or AC tube placement; (3) question remains whether a sulcus tube cause more AC microenvironment change due to higher chance of having chronic tube-iris touch than an AC tube, jeopardizing endothelial cell health, IOP control, or other surgical outcomes of the sulcus tube. To answer these questions, we propose a multi-center, outcome-masked clinical trial randomizing 240 subjects to sulcus tube versus AC tube placement. In this trial, we will compare ECL (specific aim 1), IOP control (specific aim 2) and AC microenvironment (specific aim 3) after GDD implantation with tube placement in the ciliary sulcus versus the anterior chamber. In the setting of increased use of gdds, our proposed trial to identify better approaches to decrease its corneal complications is of substantial interest to both corneal and glaucoma specialists. Department of ophthalmology at university of california SAN francisco (ucsf), francis i. Proctor foundation at ucsf, university of pennsylvania (upenn), and 4 high-volume centers for GDD implantation will jointly execute this trial. The department of ophthalmology at ucsf will serve as clinical coordinating center. Upenn will be the data coordinating center. Francis i. Proctor foundation will be the imaging reading center and metagenomic RNA deep sequencing analysis (MDS) center. This trial is innovative for a number of reasons including the randomization of surgery (sulcus tube versus AC tube) and application of novel MDS analysis (examining postoperative AC microenvironment), none of which has been prospectively studied before. IT is aligned with the priorities of the NEI, studying high- resolution imaging techniques such as endothelial cell imaging and anterior-segment optical coherence 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 important questions presented in this proposal.

Transactions

Action Obligated Date
Amendment $14,580
Amendment $1,068,539
Amendment $1,038,103
Amendment $1,049,710
Amendment $1,049,710
Amendment $1,191,591
Original award $1,191,591

Subawards

Subrecipient Amount Awarded
The Johns Hopkins University Glaucoma Specialists/Ophthalmologists (Subcontract Principal Investigator, Project Co-Investigator) o Assume responsibility for the study in the absence of… $95,826
Subrecipient not on record Site Sub-Principal Investigator: Ensure the execution of the study as per the protocol Responsible for identifying eligible patients, ensuring that… $106,650
The Research Foundation For The State University Of New York • Assume responsibility for the study in the absence of the Principal Investigator • Responsible for identifying eligible patients • Provide… $129,994
University Of North Carolina At Chapel Hill Prepare reports regarding recruitment and follow-up progress. Coordinate with coordinating center. Ensure completion of data entry and query response by… $74,424
Massachusetts Eye And Ear Infirmary Assume responsibility for the study in the absence of the Principal Investigator • Responsible for identifying eligible patients • Provide… $114,415
The Leland Stanford Junior University Jennifer Rose-Nussbuamer, MD, Associate Professor of Ophthalmology at Byers Eye Institute at Stanford University, will serve as co-Principal Investigator of… $544,577
University Of Miami Project Title: Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial Start/End Dates: 0 4/0 1 /2 0 2 3 – 0 3/3 1/2 0 2 8… $96,921
Prism Eye Institute Inc. Project Title: Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial Start/End Dates: 4/1/2023 – 3/31/2028 SubPI Name:… $166,628
The Trustees Of The University Of Pennsylvania Project Title: Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial Start/End Dates: 04/01/2023 – 03/31/2028 SubPI Name:… $1,357,818

Quick answers

Who received award UG1EY033703?

UG1EY033703 was awarded to The Regents Of The University Of California. San Francisco by National Eye Institute (National Institutes of Health) on April 1, 2023.

How much is award UG1EY033703 worth?

$6,603,824 has been obligated on UG1EY033703.

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