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Not yet recruitingNCT07880132Updated Oct 19, 2026

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.

An interventional study of GORE Glaucoma Drainage Implant in Glaucoma, Primary Open Angle, sponsored by Gore Ophthalmic. Not yet recruiting. Open to participants aged 46 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Gore Ophthalmic · Not applicable, Interventional, and Device feasibility

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
46 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Glaucoma, Primary Open Angle

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03

In context

Glaucoma, Open-Angle

943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's planned enrollment of 70 is below the median of 80 across 710 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

This is the only study on the registry with Gore Ophthalmic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
46 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    GORE Glaucoma Drainage Implant

    Device: GORE Glaucoma Drainage Implant

Interventions

  • DeviceGORE Glaucoma Drainage Implant

    GDI-01

06

What researchers measure

Primary outcomes

  1. Percent Change in MDIOP

    Percent change in MDIOP at the 12-Month Visit compared to the Baseline Visit.

    Time frame: 12 Months

  2. 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

    Time frame: 12 Months

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07880132
Lead sponsor
Gore Ophthalmic
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2028 (estimated)
Completion
Oct 2030 (estimated)
Last update
Oct 19, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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