Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

NCT05924477 | Recruiting DMC

• 2 other identifiers: 853474UG1EY033703
• Study Type: interventional
• Target: 226
• Locations: 2 countries
• Sites: 8

Brief Summary

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.

Conditions

Glaucoma

Keywords

glaucoma; glaucoma drainage device; endothelial cell density; endothelial cell loss; intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Central endothelial cell loss (ECL) from baseline

  Change in central endothelial cell density based on assessment of Specular Microscopy images.

  Baseline to 12 months

Secondary Outcomes (4)

• Intraocular Pressure (IOP) at 12 months

  12 months after GDD implantation

• ECD at 12 months after GDD implantation

  12 months after GDD implantation

• Best-corrected visual acuity (BCVA) at 12 months after GDD implantation

  12 months after GDD implantation

• Number of anti-glaucoma medications at 12 months after GDD implantation

  12 months after GDD implantation

Other Outcomes (7)

• MDS (Metagenomic RNA Deep Sequencing) analysis at 12 months

  12 months after GDD implantation

• Central endothelial cell loss (ECL) from baseline

  Baseline to 24 months

• Intraocular Pressure (IOP) at 24 months

  24 months after GDD implantation

Study Arms (2)

Sulcus tube placement

ACTIVE COMPARATOR

Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus

Procedure: Sulcus tube placement

Anterior chamber (AC) tube placement

ACTIVE COMPARATOR

Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber

Procedure: Anterior chamber (AC) tube placement

Interventions

Sulcus tube placement PROCEDURE

GDD implantation surgery with tube placement in the ciliary sulcus

Sulcus tube placement

Anterior chamber (AC) tube placement PROCEDURE

GDD implantation surgery with tube placement in the anterior chamber

Anterior chamber (AC) tube placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure
• Candidate for GDD implantation for ciliary sulcus and AC tube
• Age greater than or equal to 18 years old

You may not qualify if:

• Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant
• Presence or history of Cypass Micro-Stent
• Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery
• Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt
• Previous trabeculectomy and/or minimally invasive glaucoma surgery within the past 6 months
• AC intraocular lens
• Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
• No light perception vision in the study eye or fellow eye visual acuity \< 20/200
• Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Eye Institute (NEI): collaborator
• University of California, San Francisco: collaborator
• Stanford University: collaborator

Study Sites (8)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Diablo Eye Associates

Walnut Creek, California, 94598, United States

RECRUITING

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

RECRUITING

Wilmer Eye Institute, Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

University of Buffalo/State University of New York

Buffalo, New York, 14203, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

RECRUITING

Prism Eye Institute, University of Toronto

Toronto, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Ying Han, MD, PhD

  University of California, San Francisco

  STUDY CHAIR

• Jennifer Rose-Nussbaumer, MD

  Stanford University

  STUDY DIRECTOR

• Thuy Doan, MD, PhD

  University of California San Fransicso

  STUDY DIRECTOR

Central Study Contacts

Gui-shuang Ying, PhD

CONTACT

215-615-1514; gsying@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All trial participants will be masked to their tube locations. The primary outcome accessors who grade specular microscopy images at the PRC, perform IOP measurements at each clinical center, or conduct the MDS analysis at the Metagenomic RNA Deep Sequencing (RNA-seq) Center will also be masked to tube locations. Due to the nature of the surgical intervention, the surgeon, the technician taking specular microscopy and AS-OCT images, and the graders at the PRC who will perform AS-OCT measurements will not be masked to the tube locations. However, the graders of AS-OCT images will be masked to the purpose of the study and will be different from the graders of specular microscopy images.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective 1:1 randomized, parallel design, double-masked clinical trial. Stratification is by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification).

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 29, 2023
• Study Start: July 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (1)