NCT07880132Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
A Prospective, Multicenter, Single-Cohort, Open-Label Clinical Study Designed to Evaluate the Safety and Effectiveness of the GORE® Glaucoma Drainage Implant (GORE GDI) in Subjects With Primary Open Angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 12 Oct 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Gore Ophthalmic
- Diseases
- Glaucoma
- NCT number
- NCT07880132
What you commit to
- Study type: Interventional
- Planned participants: 70
- From Oct 2026 to the primary completion date, Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any pathology or condition (including prior glaucoma filtration or conjunctival surgery) that prevents implantation of the study device in the target quadrant
- History of corneal transplantation, prior corneal surgery, corneal opacities inhibiting visualization, or clinically significant corneal disease pathology
Other illness
- Diagnosis of degenerative visual disorders
Other
- Closed-angle and secondary glaucomas
- Non-study eye with BCVA worse than 20/200
- Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Who the study is looking for
- Diagnosis of primary open-angle glaucoma (POAG) with IOP uncontrolled by medical therapy and failed surgical treatment
- Medicated IOP of \>=20 mmHg
- Shaffer angle grade \>= 2 in target quadrant
- Area of free and mobile conjunctiva without extensive scarring or fibrosis
- At least 46 years old
Age in the registry: 46 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.