Primary Open Angle GlaucomaNCT01563237

Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) Glaucoma Drainage Implant

A study testing MIDI Arrow in people with Primary Open Angle Glaucoma, run by InnFocus Inc. at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To assess the safety and performance of the MIDI Arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm Hg and ≤ 40 mm Hg Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Primary Open Angle Glaucoma
What is being tested?: MIDI Arrow
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 1 siteFrance
Study dates: Jun 2011to Jan 2017
Phase: Interventional
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 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patient, age 18 to 85 years, inclusive
Patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
Patient must have signed and dated the Informed Consent form

Who cannot join

Unwilling or unable to give informed consent or unable to return for scheduled protocol visits.
Pregnant or nursing women.
No light perception.
Active iris neovascularization or active proliferative retinopathy.
Iridocorneal endothelial syndrome.
Epithelial or fibrous downgrowth.

Show all 18Show fewer

Pseudoexfoliative glaucoma
Aphakia.
Vitreous in anterior chamber for which a vitrectomy is anticipated.
Corneal disease
Acute, chronic or recurrent uveitis.
Severe posterior blepharitis.
Unwilling to discontinue contact lens use after surgery.
Previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery.
Prior cataract surgery involving a conjunctival incision
Need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period.
Less than 0.1 (20/200) visual acuity in the non-test eye.
Infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.

Trial locations and contacts

1 site in 1 country.

France1 site

Clinique Mutualiste - Pavillon Ophtalmogique
Pessac, 33600

Other trials in France

About this study

Official title: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms

Read the detailed description

This will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a MIDI Arrow in the anterior chamber of the eye. Patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. Safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. The effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.

Conditions: Primary Open Angle Glaucoma
Being tested: MIDI Arrow
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.

MIDI ArrowDevice
Also called Glaucoma drainage device implantation
Implantation of MIDI Arrow

Study groups in NCT01563237
Study group	Role	What they receive
MIDI Arrow	Experimental	Implantation of MIDI Arrow Receives: Device: MIDI Arrow

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Eyes With Study Success
The rate of success reflected sustained control of IOP over 24 Months from baseline
Measured: Months 6, 9, 12 and 24

Secondary outcomes (1)

IOP Change From Baseline
Intraocular Pressure (IOP) change in studied eye compared to baseline value at all timepoints thru 24 Months.
Measured: At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jan 2017

First posted26 Mar 2012 (estimated)
Study startJun 2011
Primary completionDec 2016
Study completionJan 2017

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.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01563237
Sponsor's protocol ID: INN004
Status last verified: Jun 2021
First submitted: 21 Mar 2012
Last updated: 24 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Garcia-Feijoo J, Batlle JF, Aptel F, Lachkar Y, Riss I, Sadruddin O, Nguyen T, Beckers HJM. Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C. Ophthalmol Ther. 2025 Jul;14(7):1533-1549. doi: 10.1007/s40123-025-01149-4. Epub 2025 May 23.
PubMed 40408035

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Performance of Miami InnFocus Drainage Implant (MIDI Arrow) to Relieve Glaucoma Symptoms
ClinicalTrials.gov ID: NCT01563237
Acronym / sponsor ID: INN004
Conditions: Primary Open Angle Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: InnFocus Inc.Industry (pharma, biotech, devices)
Study start: Jun 2011
Primary completion: Dec 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 26 Mar 2012 (estimated)
Results: Posted 28 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MIDI Arrow	Experimental	Device: MIDI ArrowImplantation of MIDI Arrow

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female patient, age 18 to 85 years, inclusive
Patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
Patient must have signed and dated the Informed Consent form

Key exclusion criteria (18 listed)

Unwilling or unable to give informed consent or unable to return for scheduled protocol visits.
Pregnant or nursing women.
No light perception.
Active iris neovascularization or active proliferative retinopathy.
Iridocorneal endothelial syndrome.

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
MIDI ArrowAlso: Glaucoma drainage device implantationImplantation of MIDI Arrow	Device	MIDI Arrow

Primary outcome

Number of Eyes With Study Success
Time frame: Months 6, 9, 12 and 24
The rate of success reflected sustained control of IOP over 24 Months from baseline

1 secondary outcome

IOP Change From Baseline
Time frame: At Day 1, Day 7, Week 3, Week 6, Month 3, Month 9, Month 12 and Month 24

Results and safety

Results posted to the registry on 28 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First Studied Eye	64	54
Second Studied Eye	5	5

Primary outcome: Number of Eyes With Study Success

Time frame: Months 6, 9, 12 and 24. Count of units. Unit: Implanted eyes

Measure	Success With Respect to IOP n = 67
Month 6	50
Month 9	52
Month 12	50
Month 24	51

Population analysed: The Intent-to-Treat (ITT) population included all enrolled eyes who have signed the informed consent and attended the procedure visit to receive the assigned therapy under evaluation (MIDI Arrow).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were reported for the duration of the study of 24 Months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Eyes Selected to be Operated Within the Study	10 of 74 (13.5%)	68 of 74 (91.9%)	1 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40408035Garcia-Feijoo J, Batlle JF, Aptel F, Lachkar Y, Riss I, Sadruddin O, Nguyen T, Beckers HJM. Pooled Analysis of Three MicroShunt Studies in Primary Open-Angle Glaucoma Evaluating Different Concentrations of Applied Mitomycin C. Ophthalmol Ther. 2025 Jul;14(7):1533-1549. doi: 10.1007/s40123-025-01149-4. Epub 2025 May 23.

Related trials for Primary Open Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
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Active, not recruitingObservational study
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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.

Isabelle M Riss, MD principal investigator

Clinique Mutualiste de Pessac, Pessac, France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MIDI Arrow in people with Primary Open Angle Glaucoma, run by InnFocus Inc. at 1 site in France.

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 18 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 24 Jun 2021. 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 France. 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 28 May 2021). 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?

Number of Eyes With Study Success (time frame: Months 6, 9, 12 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563237, which also lists 1 linked publication.

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 24 Jun 2021.