Glaucoma, Primary Open AngleNCT07880132
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 study testing GORE Glaucoma Drainage Implant in people with Glaucoma, Primary Open Angle, run by Gore Ophthalmic.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle
- What is being tested?
- GORE Glaucoma Drainage Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Oct 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Closed-angle and secondary glaucomas
- Any pathology or condition (including prior glaucoma filtration or conjunctival surgery) that prevents implantation of the study device in the target quadrant
- Diagnosis of degenerative visual disorders
- History of corneal transplantation, prior corneal surgery, corneal opacities inhibiting visualization, or clinically significant corneal disease pathology
- Non-study eye with BCVA worse than 20/200
- Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
About this study
Official title: 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.
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.
- Conditions
- Glaucoma, Primary Open Angle
- Being tested
- GORE Glaucoma Drainage Implant
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GORE Glaucoma Drainage ImplantDevice
GDI-01
| Study group | Role | What they receive |
|---|---|---|
| GORE Glaucoma Drainage Implant | Experimental | Not described Receives: Device: GORE Glaucoma Drainage Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in MDIOP
Percent change in MDIOP at the 12-Month Visit compared to the Baseline Visit.
Measured: 12 Months
Proportion of subjects achieving a ≥ 20% reduction in MDIOP
Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP (MDIOP) at 12 months while maintaining the same or fewer number of ocular hypotensive medication classes compared to the Baseline Visit
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Primary Open AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gore Ophthalmic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880132
- Sponsor's protocol ID
- GDI 25-01
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes