Primary Open-angle GlaucomaNCT05557058
GORE Glaucoma Drainage Implant Clinical Study Dominican Republic
A study testing Gore Glaucoma Device Implant (GORE GDI) in people with Primary Open-angle Glaucoma, run by W.L.Gore & Associates at 1 site in Dominican Republic.
Trial summary
The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant configurations in subjects with primary open-angle glaucoma that is uncontrolled by hypotensive medications or for which conventional incisional glaucoma surgery would… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- Gore Glaucoma Device Implant (GORE GDI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDominican Republic
- Study dates
- 14 Sep 2022to Aug 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, 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
The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant 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.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- Gore Glaucoma Device Implant (GORE GDI)
- 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 Device Implant (GORE GDI)Device
Unilateral implantation of one of three different configurations of the GORE GDI
| Study group | Role | What they receive |
|---|---|---|
| Gore GDI High Device Arm | Experimental | Implantation of the GORE GDI High Device Configuration Receives: Device: Gore Glaucoma Device Implant (GORE GDI) |
| Gore GDI Low Device Arm | Experimental | Implantation of the GORE GDI Low Device Configuration Receives: Device: Gore Glaucoma Device Implant (GORE GDI) |
| GORE GDI Modified Device Arm | Experimental | Non-Randomized implantation of the GORE GDI Modified Device Configuration Receives: Device: Gore Glaucoma Device Implant (GORE GDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start14 Sep 2022
- Primary completion12 Feb 2027 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan F Batlle Pichardo, M.D., Principal investigator, Laser Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557058
- Sponsor's protocol ID
- GDI 21-03
- Status last verified
- Feb 2026
- First submitted
- 20 Sep 2022
- Last updated
- 19 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, 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
- ClinicalTrials.gov ID
- NCT05557058
- Acronym / sponsor ID
- GDI 21-03
- Conditions
- Primary Open-angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gore GDI High Device Arm | Experimental | Device: Gore Glaucoma Device Implant (GORE GDI)Implantation of the GORE GDI High Device Configuration |
| Gore GDI Low Device Arm | Experimental | Device: Gore Glaucoma Device Implant (GORE GDI)Implantation of the GORE GDI Low Device Configuration |
| GORE GDI Modified Device Arm | Experimental | Device: Gore Glaucoma Device Implant (GORE GDI)Non-Randomized implantation of the GORE GDI Modified Device Configuration |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gore Glaucoma Device Implant (GORE GDI)Unilateral implantation of one of three different configurations of the GORE GDI | Device | GORE GDI Modified Device Arm, Gore GDI High Device Arm, Gore GDI Low Device Arm |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Batlle Pichardo, M.D. principal investigator
Laser Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gore Glaucoma Device Implant (GORE GDI) in people with Primary Open-angle Glaucoma, run by W.L.Gore & Associates at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.