Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Glaucoma Clinical Trial

— DECLARE  

Official title:

Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924477
• Other study ID #: 853474
• Secondary ID: UG1EY033703
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2023
• Est. completion date: December 2027

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: Gui-shuang Ying, PhD
• Phone: 215-615-1514
• Email: gsying[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Sulcus tube placement
GDD implantation surgery with tube placement in the ciliary sulcus
• Anterior chamber (AC) tube placement
GDD implantation surgery with tube placement in the anterior chamber

Locations

Country	Name	City	State
Canada	Prism Eye Institute, University of Toronto	Toronto
United States	Massachusetts Eye and Ear	Boston	Massachusetts
United States	University of Buffalo/State University of New York	Buffalo	New York
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	University of California San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Pennsylvania	National Eye Institute (NEI), Stanford University, University of California, San Francisco

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Central endothelial cell loss (ECL) from baseline	Change in central endothelial cell density based on assessment of Specular Microscopy images.	Baseline to 24 months
Other	Intraocular Pressure (IOP) at 24 months	Goldman applanation tonometry (preferred method)	24 months after GDD implantation
Other	ECD at 24 months after GDD implantation	ECD measures will be based on the assessment of Specular Microscopy images	24 months after GDD implantation
Other	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
Other	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
Other	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
Primary	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	Intraocular Pressure (IOP) at 12 months	Goldman applanation tonometry (preferred method)	12 months after GDD implantation
Secondary	ECD at 12 months after GDD implantation	ECD measures will be based on the assessment of Specular Microscopy images	12 months after GDD implantation
Secondary	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
Secondary	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