Evaluating a new glaucoma drainage implant in patients with uncontrolled glaucoma

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

This study is testing a new glaucoma drainage implant to see if it can help people with uncontrolled glaucoma who haven't found relief from medications or traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: W.L.Gore & Associates (Industry-sponsored)
• Locations: 1 site (Santo Domingo)
• Trial ID: NCT05557058 on ClinicalTrials.gov

What this trial studies

This clinical study aims to assess the safety and effectiveness of the GORE Glaucoma Drainage Implant in individuals suffering from primary open-angle glaucoma that is not adequately managed with medication or where traditional surgery may fail due to scarring. Participants will receive the implant and be monitored for outcomes related to intraocular pressure and overall eye health. The study focuses on two configurations of the implant to determine the best approach for managing this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 85 with primary open-angle glaucoma that is not controlled by medication.

Not a fit: Patients with active ocular diseases or those who have had prior corneal transplants may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with difficult-to-manage glaucoma, potentially improving their vision and quality of life.

How similar studies have performed: Other studies have explored similar glaucoma drainage devices, showing promising results, but this specific approach is relatively novel.

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.

Where this trial is running

Santo Domingo

• Laser Center — Santo Domingo, Dominican Republic (Recruiting)

Study contacts

• Principal investigator: Juan F Batlle Pichardo, M.D. — Laser Center
• Study coordinator: Mary Drew

Conditions Primary Open-angle Glaucoma