GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

Not Applicable

Recruiting

• Conditions: Primary Open-angle Glaucoma
• Interventions: Device: Gore Glaucoma Device Implant (GORE GDI)

• Registration Number: NCT05557058
• Lead Sponsor: W.L.Gore & Associates

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-14
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-09
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gore GDI High Device Arm	Gore Glaucoma Device Implant (GORE GDI)	Implantation of the GORE GDI High Device Configuration
Gore GDI Low Device Arm	Gore Glaucoma Device Implant (GORE GDI)	Implantation of the GORE GDI Low Device Configuration

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	6 months	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.

Trial Locations

Locations (1)

Laser Center; 🇩🇴 Santo Domingo, Dominican Republic