DECLARE: Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05924477
• Collaborator: National Eye Institute (NEI) (NIH), University of California, San Francisco (Other), Stanford University (Other)
• Enrollment: 226
• Locations: 5
• Arms: 2
• Anticipated Duration (Months): 54
• Patients Per Site: 45.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Procedure: Sulcus tube placement; Procedure: Anterior chamber (AC) tube placement	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 226 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).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).
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2027

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Central endothelial cell loss (ECL) from baseline [Baseline to 12 months]

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

Secondary Outcome Measures

1. Intraocular Pressure (IOP) at 12 months [12 months after GDD implantation]

   Goldman applanation tonometry (preferred method)

2. ECD at 12 months after GDD implantation [12 months after GDD implantation]

   ECD measures will be based on the assessment of Specular Microscopy images

3. Best-corrected visual acuity (BCVA) at 12 months after GDD implantation [12 months after GDD implantation]

   Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.

4. Number of anti-glaucoma medications at 12 months after GDD implantation [12 months after GDD implantation]

   Topical and oral anti-glaucoma medication information is collected at all visits.

Other Outcome Measures

1. MDS (Metagenomic RNA Deep Sequencing) analysis at 12 months [12 months after GDD implantation]

   Gene profile analysis evaluating anterior chamber microenvironment (by collecting aqueous fluid samples from the study eye)

2. Central endothelial cell loss (ECL) from baseline [Baseline to 24 months]

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

3. Intraocular Pressure (IOP) at 24 months [24 months after GDD implantation]

   Goldman applanation tonometry (preferred method)

4. ECD at 24 months after GDD implantation [24 months after GDD implantation]

   ECD measures will be based on the assessment of Specular Microscopy images

5. Best-corrected visual acuity (BCVA) at 24 months after GDD implantation [24 months after GDD implantation]

   Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.

6. Number of anti-glaucoma medications at 24 months after GDD implantation [24 months after GDD implantation]

   Topical and oral anti-glaucoma medication information is collected at all visits.

7. Safety outcomes: surgical complications [At the GDD surgery visit, and up to 24 months after GDD implantation]

   All AEs, including hypotony, hyphema, tub-related complications, tube exposure, choroidal detachment, corneal decompensation, endophthalmitis and others.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

• Previous GDD implantation or Xen Gel Stent or placement of Cypass Micro-stent or 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94143
2	Bascom Palmer Eye Institute	Miami	Florida	United States	33136
3	Massachusetts Eye and Ear	Boston	Massachusetts	United States	02114
4	University of Buffalo/State University of New York	Buffalo	New York	United States	14203
5	Prism Eye Institute, University of Toronto	Toronto		Canada

Sponsors and Collaborators

• University of Pennsylvania
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT05924477
• Other Study ID Numbers: 853474; UG1EY033703
• First Posted: Jun 29, 2023
• Last Update Posted: Jun 29, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Pennsylvania: glaucoma; glaucoma drainage device; endothelial cell density; endothelial cell loss; intraocular pressure
• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Jun 29, 2023