GORE Glaucoma Drainage Implant Clinical Study

Primary Open-angle Glaucoma Clinical Trial

Official title:

A Prospective, Randomized, Single-Center, Early Feasibility Clinical Study Designed to Evaluate the Safety and Effectiveness of the GORE Glaucoma Drainage Implant (GORE GDI) in Subjects With Primary Open-Angle Glaucoma Uncontrolled by Hypotensive Medications or for Which Conventional Incisional Glaucoma Surgery Would be More Likely to Fail Due to Scarring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557058
• Other study ID #: GDI 21-03
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: April 2025

Study information

• Verified date: September 2023
• Source: W.L.Gore & Associates
• Contact: Kathy Sullivan
• Phone: 9288643266
• Email: kasulliv[@]wlgore.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (2 configurations) in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would be more likely to fail due to scarring.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Males and females, age 18 to 85 years, inclusive at screening visit

• A diagnosis of primary open-angle glaucoma (Shaffer angle = 3 as seen on gonioscopy) at screening visit

• Medicated intraocular pressure at screening visit and the mean medicated diurnal IOP at baseline visit = 18 mmHg and = 40 mmHg by Goldmann Applanation Tonometry

Exclusion Criteria:

• Expected inability to implant the study device in the superotemporal quadrant (e.g., a lack of freely mobile conjunctiva to cover the entire implanted device in the superotemporal quadrant)

• Diagnosis of any active ocular disease or disorder (other than glaucoma) that requires treatment, where the disease or treatment could be reasonably expected to affect the vision or IOP during the duration of the study

• Prior corneal transplant surgery (full or partial thickness transplants) or clinically significant corneal dystrophy, e.g., Fuchs' dystrophy (> 12 confluent guttae) in the study eye

• Concurrent cataract surgery or anticipated need for cataract surgery (i.e., clinically significant cataract) in the study eye during the 12 months following implantation

• BCDVA worse than 20/200 in the fellow (non-study) eye at the screening visit and BCDVA of the fellow eye cannot be worse than that of the study eye.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Device:
• Gore Glaucoma Device Implant (GORE GDI)
Unilateral implantation of one of two different configurations of the GORE GDI

Locations

Country	Name	City	State
Dominican Republic	Laser Center	Santo Domingo

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

Dominican Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Effectiveness Endpoint	The proportion of treated eyes with = 20% decrease in mean diurnal IOP at 6 months while maintaining the same or fewer number of hypotensive medications as at baseline.	6 months