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Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial

Award Number: UG1EY033703
ORGANIZATION: NATIONAL EYE INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2023
PERIOD OF PERFORMANCE END DATE: 03/31/2028

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Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial - PROJECT SUMMARY/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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,083,119 )
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	001	4	5/7/2026	SUPPLEMENT FOR EXPANSION	$14,580
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	000	4	4/23/2026	NON-COMPETING CONTINUATION	$1,068,539
														Subtotal = $1,083,119

Issue Date FY: 2025 ( Subtotal = $1,038,103 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	000	3	3/26/2025	NON-COMPETING CONTINUATION	$1,038,103
														Subtotal = $1,038,103

Issue Date FY: 2024 ( Subtotal = $1,049,710 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Vision Research	000	2	4/12/2024	NON-COMPETING CONTINUATION	$1,049,710
														Subtotal = $1,049,710

Issue Date FY: 2023 ( Subtotal = $1,191,591 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Vision Research	000	1	3/31/2023	NEW	$1,191,591
														Subtotal = $1,191,591

Grand Total All Awards = $4,362,523

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Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial

Award Number: UG1EY033703

ORGANIZATION: NATIONAL EYE INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2023

PERIOD OF PERFORMANCE END DATE: 03/31/2028

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