GORE Glaucoma Drainage Implant Clinical Study Dominican Republic

NCT05557058 | Active Not Recruiting

• 1 other identifier: GDI 21-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Gore GDI High Device Arm

EXPERIMENTAL

Implantation of the GORE GDI High Device Configuration

Device: Gore Glaucoma Device Implant (GORE GDI)

Gore GDI Low Device Arm

EXPERIMENTAL

Implantation of the GORE GDI Low Device Configuration

Device: Gore Glaucoma Device Implant (GORE GDI)

GORE GDI Modified Device Arm

EXPERIMENTAL

Non-Randomized implantation of the GORE GDI Modified Device Configuration

Device: Gore Glaucoma Device Implant (GORE GDI)

Interventions

Gore Glaucoma Device Implant (GORE GDI) DEVICE

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

GORE GDI Modified Device Arm; Gore GDI High Device Arm; Gore GDI Low Device Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (1)

Laser Center

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Juan F Batlle Pichardo, M.D.

  Laser Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 27, 2022
• Study Start: September 14, 2022
• Primary Completion (Estimated): February 12, 2027
• Study Completion (Estimated): August 1, 2031
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

DO (1)