GORE Glaucoma Drainage Implant Clinical Study
Study Details
Study Description
Brief Summary
The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of the GORE Glaucoma Drainage Implant (2 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Gore GDI High Device Arm Implantation of the GORE GDI High Device Configuration |
Device: Gore Glaucoma Device Implant (GORE GDI)
Unilateral implantation of one of two different configurations of the GORE GDI
|
| Experimental: Gore GDI Low Device Arm Implantation of the GORE GDI Low Device Configuration |
Device: Gore Glaucoma Device Implant (GORE GDI)
Unilateral implantation of one of two different configurations of the GORE GDI
|
Outcome Measures
Primary Outcome Measures
- Primary Effectiveness Endpoint [6 months]
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.
Eligibility Criteria
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
-
Best-corrected distance visual acuity (BCDVA) of 20/200 or worse in the study eye at screening visit
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Patients with a natural crystalline lens (phakic eye) without clinically significant cataract or patients who have previously undergone uncomplicated cataract surgery with implantation of a posterior chamber intraocular lens (pseudophakic eyes) at screening visit
-
Patients must have uncontrolled glaucoma at screening visit, which meet at least one of the following criteria:
-
IOP not fully controlled by maximum tolerated medical therapy (i.e., ≥ 3 classes of topical IOP-lowering medications or fewer in cases of tolerability or efficacy issues); or
-
Have conjunctival scarring where a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail
-
Medicated intraocular pressure at screening visit and the mean medicated diurnal IOP at baseline visit ≥ 18 mmHg and ≤ 40 mmHg by Goldmann Applanation Tonometry
-
Minimum central endothelial cell density of 1500 cells/mm2
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No vitreous prolapse present and no risk of vitreous prolapse during or after filtering surgery
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Patients must be able to comprehend the study requirements and provide written informed consent
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Patients must be willing to follow study instructions, agree to comply with all study procedures, and able to return for all scheduled follow-up examinations for at least 12 months postoperatively (the study duration may be extended up to 5 years).
Exclusion Criteria:
-
Diagnosis of exfoliating, pigmentary, neovascular, uveitic or congenital glaucoma or angle malformations/abnormalities associated with these conditions (e.g., presence of rubeosis in any area, significant peripheral anterior synechiae (PAS) in the quadrant of implantation that would impact positioning or postoperative clinical performance of the implant
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Diagnosis of acute angle-closure or malignant glaucoma
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Diagnosis of active bacterial conjunctivitis, corneal ulcers, endophthalmitis, orbital cellulitis, sinusitis, blepharitis, local skin infection, bacteremia or septicemia, scleritis
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Active, chronic, or recurrent uveitis
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Previous cilioablative procedure (e.g., cryotherapy, cyclodiode therapy)
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Previous scleral buckling procedure or presence of silicone oil
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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)
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Diagnosis of glaucoma related to high episcleral venous pressure (e.g., Sturge-Weber Syndrome)
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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
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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
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Concurrent cataract surgery or anticipated need for cataract surgery (i.e., clinically significant cataract) in the study eye during the 12 months following implantation
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Aphakic eyes
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Cataract surgery conducted < 6 months prior to study initiation
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BCDVA worse than 20/200 in the fellow (non-study) eye at the screening visit
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Pregnant or nursing women; or women of childbearing potential not willing to use medically acceptable birth control from screening through 12-month follow-up visit
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Current participation or participation within the past 30 calendar days in another interventional investigational drug or device clinical study
-
Known or suspected allergy or hypersensitivity to any device component (e.g., silicone)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laser Center | Santo Domingo | Dominican Republic |
Sponsors and Collaborators
- W.L.Gore & Associates
Investigators
- Principal Investigator: Juan F Batlle Pichardo, M.D., Laser Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GDI 21-03