GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

NCT ID: NCT05557058

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-14
• Study Completion Date: 2026-04-30

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.

Conditions

Primary Open-angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gore GDI High Device Arm

Implantation of the GORE GDI High Device Configuration

Group Type: EXPERIMENTAL

Gore Glaucoma Device Implant (GORE GDI)

Intervention Type: DEVICE

Unilateral implantation of one of two different configurations of the GORE GDI

Gore GDI Low Device Arm

Implantation of the GORE GDI Low Device Configuration

Group Type: EXPERIMENTAL

Gore Glaucoma Device Implant (GORE GDI)

Intervention Type: DEVICE

Unilateral implantation of one of two different configurations of the GORE GDI

Interventions

Gore Glaucoma Device Implant (GORE GDI)

Unilateral implantation of one of two different configurations of the GORE GDI

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan F Batlle Pichardo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Laser Center

Locations

Laser Center

Santo Domingo, , Dominican Republic

Countries

Dominican Republic

Other Identifiers

GDI 21-03

Identifier Type: -

Identifier Source: org_study_id