Primary Open-angle GlaucomaNCT04333433
PRESERFLO® MicroShunt Extension Study
An observational study of Primary Open-angle Glaucoma, run by InnFocus Inc. at 23 sites in 5 countries.
Trial summary
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- PRESERFLO® MicroShunt and Trabeculectomy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 279 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 22 May 2020to 24 Nov 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: The study population includes all living subjects who have completed the Month 24 Follow-Up Visit of the INN-005 clinical study after randomization to either the PRESERFLO® MicroShunt treatment arm or the Trabeculectomy control arm, and who are willing and able to extend their study participation and return for up to three (3) additional annual follow-up visits through post-operative Month 60. Up to 629 subjects may be enrolled at up to 24 sites located in the United States and at up to 5 sites located in Europe
Who may be able to join
- Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
- Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
- Subject is willing and able to comply with all study requirements, including signing an informed consent form.
Who cannot join
- 1. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
United States19 sites
Ophthalmic Partners of Pennsylvania
Bala-Cynwyd, Pennsylvania, 19004
Minnesota Eye Consultants, PA
Bloomington, Minnesota, 55431
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Ophthalmic Surgeons and Consultants of Ohio
Columbus, Ohio, 43215
Glaucoma Associates of Texas
Dallas, Texas, 75231
Intermountain Eye Center
Eagle, Idaho, 83616
Vold Vision
Fayetteville, Arkansas, 72704
Ophthalmology Associates
Fort Worth, Texas, 76102
Arizona Advance Eye Research Institute, LLC.
Glendale, Arizona, 85306
University Eye Associates
Houston, Texas, 77030
Eugene and Marilyn Glick Eye Institute
Indianapolis, Indiana, 46290
UCLA Medical Center Jules Stein Eye Institute
Los Angeles, California, 90095
Ophthalmic Consultants of Connecticut
Meriden, Connecticut, 06450
New York Eye and Ear Infirmary of Mt. Sinai
New York, New York, 10003
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73014
Stiles Eye Care Excellence & Glaucoma Institute
Overland Park, Kansas, 66213
University of California at Davis Eye Center
Sacramento, California, 95817
R&R Eye Research, LLC
San Antonio, Texas, 78229
Glaucoma Consultants of the Capital Region
Slingerlands, New York, 12159
France1 site
Pôle Ophtalmologique de la Clinique Mutualiste
Pessac, Bordeaux, 33600
Italy1 site
A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello
Pisa, Cisanello, 56124
About this study
Official title: A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.
Read the detailed description
The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-005 clinical study, by collecting safety data through 5 years post-operative follow-up.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- PRESERFLO® MicroShunt, Trabeculectomy
- Keywords
- POAG
- 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.
PRESERFLO® MicroShuntDevice
Also called InnFocus MicroShunt® Glaucoma Drainage System
Device surgically implanted
TrabeculectomyProcedure or surgery
The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
| Study group | Role | What they receive |
|---|---|---|
| MicroShunt treatment group | Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device Receives: Device: PRESERFLO® MicroShunt | |
| Trabeculectomy control arm | Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Sight-threatening Adverse Events
Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.
Measured: Month 36 thru Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start22 May 2020
- Primary completion24 Nov 2022
- Study completion24 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Open-angle GlaucomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnFocus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Palmberg, MD, PhD, Study director, Bascolm Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333433
- Sponsor's protocol ID
- INN005 - EXT
- Status last verified
- Sep 2023
- First submitted
- 1 Apr 2020
- Last updated
- 22 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04333433
- Acronym / sponsor ID
- INN005 - EXT
- Conditions
- Primary Open-angle Glaucoma
- Keywords
- POAG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- InnFocus Inc.Industry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 24 Nov 2022 (actual)
- Study completion
- 24 Nov 2022 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Posted 22 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.
Detailed description
The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-005 clinical study, by collecting safety data through 5 years post-operative follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MicroShunt treatment group | – | Device: PRESERFLO® MicroShuntSubjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device |
| Trabeculectomy control arm | – | Procedure: TrabeculectomySubjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes all living subjects who have completed the Month 24 Follow-Up Visit of the INN-005 clinical study after randomization to either the PRESERFLO® MicroShunt treatment arm or the Trabeculectomy control arm, and who are willing and able to extend their study participation and return for up to three (3) additional annual follow-up visits through post-operative Month 60. Up to 629 subjects may be enrolled at up to 24 sites located in the United States and at up to 5 sites located in Europe
Key inclusion criteria (3 listed)
- Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028.
- Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included).
- Subject is willing and able to comply with all study requirements, including signing an informed consent form.
Key exclusion criteria (1 listed)
- 1. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.
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 |
|---|---|---|
| PRESERFLO® MicroShuntAlso: InnFocus MicroShunt® Glaucoma Drainage SystemDevice surgically implanted | Device | MicroShunt treatment group |
| TrabeculectomyThe procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away. | Procedure or surgery | Trabeculectomy control arm |
Primary outcome
Incidence of Sight-threatening Adverse Events
Time frame: Month 36 thru Month 60
Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Palmberg, MD, PhD study director
Bascolm Palmer Eye Institute
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open-angle Glaucoma, run by InnFocus Inc. at 23 sites in 5 countries.
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 1 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: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, France, Italy, Spain, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 22 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Sight-threatening Adverse Events (time frame: Month 36 thru Month 60). 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 22 Mar 2024.