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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: Sulcus tube placement; Procedure: Anterior chamber (AC) tube placement

Detailed Description

The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation.

The trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up.

Patients will be randomized to 2 tube locations for GDD implantation:

• Tube placed in the AC
• Tube placed in ciliary sulcus
• Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gui-Shuang Ying, PhD; Phone Number: 215-615-1514; Email: gsying@pennmedicine.upenn.edu

Study Locations

• Canada
  • Toronto, Canada
    • Recruiting
    • Prism Eye Institute, University of Toronto
    • Contact: Iqbal Ike Ahmed, MD, PhD
• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: Ying Han, MD, PhD
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Diablo Eye Associates
      • Contact: Yen Cheng Hsia, MD
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Bascom Palmer Eye Institute
      • Contact: Steven Gedde, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Wilmer Eye Institute, Johns Hopkins University
      • Contact: Pradeep Yammanuru Ramulu, MD, PhD
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts Eye and Ear
      • Contact: Teresa Chen, MD
  • New York
    • Buffalo, New York, United States, 14203
      • Recruiting
      • University of Buffalo/State University of New York
      • Contact: Asher Weiner, MD
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Donald Budenz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sulcus tube placement; Glaucoma drainage device (GDD) implantation with tube placement in the ciliary sulcus	Procedure: Sulcus tube placement; GDD implantation surgery with tube placement in the ciliary sulcus
Active Comparator: Anterior chamber (AC) tube placement; Glaucoma drainage device (GDD) implantation with tube placement in the anterior chamber	Procedure: Anterior chamber (AC) tube placement; GDD implantation surgery with tube placement in the anterior chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraocular Pressure (IOP) at 12 months	Goldman applanation tonometry (preferred method)	12 months after GDD implantation
ECD at 12 months after GDD implantation	ECD measures will be based on the assessment of Specular Microscopy images	12 months after GDD implantation
Best-corrected visual acuity (BCVA) at 12 months after GDD implantation	Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.	12 months after GDD implantation
Number of anti-glaucoma medications at 12 months after GDD implantation	Topical and oral anti-glaucoma medication information is collected at all visits.	12 months after GDD implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MDS (Metagenomic RNA Deep Sequencing) analysis at 12 months	Gene profile analysis evaluating anterior chamber microenvironment (by collecting aqueous fluid samples from the study eye)	12 months after GDD implantation
Central endothelial cell loss (ECL) from baseline	Change in central endothelial cell density based on assessment of Specular Microscopy images.	Baseline to 24 months
Intraocular Pressure (IOP) at 24 months	Goldman applanation tonometry (preferred method)	24 months after GDD implantation
ECD at 24 months after GDD implantation	ECD measures will be based on the assessment of Specular Microscopy images	24 months after GDD implantation
Best-corrected visual acuity (BCVA) at 24 months after GDD implantation	Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.	24 months after GDD implantation
Number of anti-glaucoma medications at 24 months after GDD implantation	Topical and oral anti-glaucoma medication information is collected at all visits.	24 months after GDD implantation
Safety outcomes: surgical complications	All AEs, including hypotony, hyphema, tub-related complications, tube exposure, choroidal detachment, corneal decompensation, endophthalmitis and others.	At the GDD surgery visit, and up to 24 months after GDD implantation

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Eye Institute (NEI); University of California, San Francisco; Stanford University
• Investigators: Study Chair: Ying Han, MD, PhD, University of California, San Francisco; Study Director: Jennifer Rose-Nussbaumer, MD, Stanford University; Study Director: Thuy Doan, MD, PhD, University of California San Fransicso

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 8, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: intraocular pressure; glaucoma; endothelial cell density; glaucoma drainage device; endothelial cell loss
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 853474; UG1EY033703 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No