Primary Open Angle Glaucoma (POAG)NCT02434692
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
A study testing ARGOS-IO system in people with Primary Open Angle Glaucoma (POAG), run by Implandata Ophthalmic Products GmbH at 11 sites in Germany.
Trial summary
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG)
- What is being tested?
- ARGOS-IO system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 11 sitesGermany
- Study dates
- 9 Jul 2014to 11 Apr 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mentally competent and willing to provide written informed consent
- Male or female aged ≥40 and ≤85 years. Female subjects of childbearing potential must be willing to use adequate contraception and must have a negative pregnancy test.
- Diagnosis of primary open-angle glaucoma (POAG) including high pressure glaucoma (HPG), normal pressure glaucoma (NPG) and ocular hypertension (OH), as defined by the European Glaucoma Society guideline (Heijl, Treverso, et al., 2008)
- Sufficiently controlled intraocular pressure (IOP)
- Study eye needs to be phakic
- Only one eye per patient may be implanted with the ARGOS-IO implant
Show all 11Show fewer
- Cataract surgery indicated. The medical indication for a cataract operation must be given irrespective of the study participation. Potential study patients will be solicited for participation in the clinical trial only after the patient has given consent to the cataract operation.
- Pre-operative anterior chamber depth (ACD) ≥2.0 mm as measured from the corneal endothelium
- Axis length >22 mm
- Endothelial cell density of the cornea ≥2000 cells/mm²
- Subjects able and willing to attend all scheduled visits and comply with all study procedures
Who cannot join
- Any other type of glaucoma other than primary open-angle glaucoma as defined by inclusion criterion 3
- Severe POAG patients with a macular degeneration and visual field loss of -20 decibels (dB) or worse in both eyes. In case of a diverse developed visual field loss, the sensor can be implanted in the worse eye for protection the better eye.
- Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
- Retinal detachment
- Corneal diseases, especially diseases affecting the corneal endothelium, e.g. Fuchs' Dystrophia
- Diabetes mellitus
Show all 27Show fewer
- Existence of Marfan-Syndrome, Ehlers-Danlos-Syndrome or Weill-Marchesani-Syndrome
- History or evidence of severe inflammatory eye diseases (i.e. uveitis, retinitis, scleritis) in one or both eyes within 6 months prior to ARGOS-IO implantation
- Intraocular surgical procedure(s) within 6 months prior to ARGOS-IO implantation or any surgical procedure such as refractive eye surgery in the study eye that can affect the assessment of IOP by Goldmann applanation tonometry
- History of eye tumor
- Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP by Goldmann applanation tonometry (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy)
- Anterior chamber configuration that puts the subject at high risk to develop an angle closure glaucoma
- History of extensive keloid formation
- Severe dry eye syndrome
- Subjects who will need to undergo ancillary procedures in the study eye at the time of implantation or during the post-operative study period
- Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, plaster or silicone (component of the device)
- Existence of other active medical eye implant and/or other active medical implants in the head/neck region
- Any contraindication for intraocular lens (IOL) implantation such as choroidal hemorrhage, concomitant severe eye disease, excessive vitreous loss, extremely shallow anterior chamber, microphthalmos, non-age-related cataract, posterior capsular rupture, severe corneal dystrophy, untraceable IOP, zonular separation, color vision deficiencies
- Severe generalized disease resulting in a life expectancy shorter than a year
- Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
- Currently pregnant or breastfeeding
- Participation in any study involving an investigational drug or device within the past 30 days or ongoing participation in a study with an investigational drug or device
- Patients who are not suitable for the study based on the surgeon's evaluation
- Patients unable or unwilling to understand or comply with required study procedures
- Patients with psychiatric disorders influencing their judgement or autonomy
- Subject and/or an immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the contract research organization.
- Enrollment of the fellow eye in this clinical study
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Augenklinik Universitätsklinikum Aachen
Aachen, 52074
Augen-Zentrum-Nordwest
Ahaus, 48683
Universitäts-Augenklinik Bochum
Bochum, 44892
Internationale Innovative Ophthalmochirurgie Breyer-Kaymak-Klabe
Düsseldorf, 40212
Augenklinik der SLK-Kliniken
Heilbronn, 74078
nordBLICK Augenklinik Bellevue
Kiel, 24105
Universitätsaugenklinik Magdeburg
Magdeburg, 39120
Augenärztliches Augenchirurgisches Zentrum (AAZ)
Nuremberg, 90403
Klinik und Poliklinik für Augenheilkunde der Universität Rostock
Rostock, 18057
Knappschaftsklinikum Saar - Augenklinik
Sulzbach, 66280
Universitäts-Augenklinik
Tübingen, 72076
About this study
Official title: A Prospective, Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-IO System in Patients With Primary Open Angle Glaucoma (POAG)
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
Read the detailed description
This prospective, open-label, multi center, single-arm clinical investigation will enroll 22 consecutive patients.
Enrollment will be temporarily halted in case a serious adverse device effect (SADE) occurs, and Data and Safety Monitoring Board (DSMB) meeting will be conducted as soon as possible. The DSMB will then recommend whether to further continue the study as planned, or whether enrollment shall be stopped. In order to provide a complete overview of the study to the DSMB, an interim analysis will be performed after half of the study population (11-14 subjects) is enrolled with a minimum follow-up of 1 month. A conclusion for safety will be made if in total no more than 2 of the total of 22 patients experience a SADE.
The primary aim of this study is to show "safety", which will be evaluated based on the percentage of subjects who experience a SADE (="non-safety"), as defined in the primary endpoints.
The study will be declared a success if the final non-safety event rate is less than 6% (type II error rate of 0.20). The calculation is based on a design optimizing the minimum expected sample size with parameters alpha=0.05, beta=0.20, p0=0.75, p1=0.94.
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Being tested
- ARGOS-IO system
- Keywords
- Primary Open Angle Glaucoma, POAG, Glaucoma, Cataract, Surgery, Ocular Pressure
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARGOS-IO systemDevice
Implantation of ARGOS-IO pressure sensor after IOL placement within the cataract surgical procedure on day 0 (V01)
| Study group | Role | What they receive |
|---|---|---|
| Single-arm intervention ARGOS-IO system | Experimental | The ARGOS-IO Pressure sensor will be additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery. Receives: Device: ARGOS-IO system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
Number of patients experiencing a device related SAE (SADE) and complications during the implantation of the ARGOS-IO device.
Measured: Day 0 to Day 360 (V01 [Implantation] to V11)
Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System
Intraclass correlation between intraocular pressure (IOP) measurements made by GAT and the ARGOS-IO system (IOP in mmHg; starting at visit V05 as specified by the protocol) following the ICC(3,k) concordance analysis method [Choritz et al., 2019 (Telemetric Measurement of … ARGOS-02 Trial) in the "References"-section].
Measured: Day 30 to Day 360 (V05 to V11)
Secondary outcomes (1)
Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
Safety evaluation based on the incidence, nature, severity and seriousness of observed adverse events and adverse device events.
Measured: Day 0 to Day 360 (V01 [Implantation] to V11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start9 Jul 2014
- Primary completion11 Apr 2017
- Study completion11 Apr 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 Glaucoma (POAG)Studies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Implandata Ophthalmic Products GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hagen Thieme, Prof., Principal investigator, University Eye Clinic Magdeburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434692
- Sponsor's protocol ID
- ARGOS-02
- Other IDs
- CIV-13-11-011719
- Status last verified
- Oct 2024
- First submitted
- 2 Sep 2014
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mansouri K, Gillmann K, Rao HL, Weinreb RN; ARGOS-2 Study Group. Weekly and seasonal changes of intraocular pressure measured with an implanted intraocular telemetry sensor. Br J Ophthalmol. 2021 Mar;105(3):387-391. doi: 10.1136/bjophthalmol-2020-315970. Epub 2020 Jun 4.
PubMed 32499329
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multicenter Clinical Investigation to Assess the Safety and Performance of the ARGOS-IO System in Patients With Primary Open Angle Glaucoma (POAG)
- ClinicalTrials.gov ID
- NCT02434692
- Acronym / sponsor ID
- ARGOS-02
- Conditions
- Primary Open Angle Glaucoma (POAG)
- Keywords
- Primary Open Angle Glaucoma, POAG, Glaucoma, Cataract, Surgery, Ocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Implandata Ophthalmic Products GmbHIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 11 Apr 2017 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in patients with POAG and indicated cataract surgery.
Detailed description
This prospective, open-label, multi center, single-arm clinical investigation will enroll 22 consecutive patients.
Enrollment will be temporarily halted in case a serious adverse device effect (SADE) occurs, and Data and Safety Monitoring Board (DSMB) meeting will be conducted as soon as possible. The DSMB will then recommend whether to further continue the study as planned, or whether enrollment shall be stopped. In order to provide a complete overview of the study to the DSMB, an interim analysis will be performed after half of the study population (11-14 subjects) is enrolled with a minimum follow-up of 1 month. A conclusion for safety will be made if in total no more than 2 of the total of 22 patients experience a SADE.
The primary aim of this study is to show "safety", which will be evaluated based on the percentage of subjects who experience a SADE (="non-safety"), as defined in the primary endpoints.
The study will be declared a success if the final non-safety event rate is less than 6% (type II error rate of 0.20). The calculation is based on a design optimizing the minimum expected sample size with parameters alpha=0.05, beta=0.20, p0=0.75, p1=0.94.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm intervention ARGOS-IO system | Experimental | Device: ARGOS-IO systemThe ARGOS-IO Pressure sensor will be additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Mentally competent and willing to provide written informed consent
- Male or female aged ≥40 and ≤85 years. Female subjects of childbearing potential must be willing to use adequate contraception and must have a negative pregnancy test.
- Diagnosis of primary open-angle glaucoma (POAG) including high pressure glaucoma (HPG), normal pressure glaucoma (NPG) and ocular hypertension (OH), as defined by the European Glaucoma Society guideline (Heijl, Treverso, et al., 2008)
- Sufficiently controlled intraocular pressure (IOP)
- Study eye needs to be phakic
Key exclusion criteria (27 listed)
- Any other type of glaucoma other than primary open-angle glaucoma as defined by inclusion criterion 3
- Severe POAG patients with a macular degeneration and visual field loss of -20 decibels (dB) or worse in both eyes. In case of a diverse developed visual field loss, the sensor can be implanted in the worse eye for protection the better eye.
- Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
- Retinal detachment
- Corneal diseases, especially diseases affecting the corneal endothelium, e.g. Fuchs' Dystrophia
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 |
|---|---|---|
| ARGOS-IO systemImplantation of ARGOS-IO pressure sensor after IOL placement within the cataract surgical procedure on day 0 (V01) | Device | Single-arm intervention ARGOS-IO system |
Primary outcome
Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
Time frame: Day 0 to Day 360 (V01 [Implantation] to V11)
Number of patients experiencing a device related SAE (SADE) and complications during the implantation of the ARGOS-IO device.
Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System
Time frame: Day 30 to Day 360 (V05 to V11)
Intraclass correlation between intraocular pressure (IOP) measurements made by GAT and the ARGOS-IO system (IOP in mmHg; starting at visit V05 as specified by the protocol) following the ICC(3,k) concordance analysis method [Choritz et al., 2019 (Telemetric Measurement of … ARGOS-02 Trial) in the "References"-section].
1 secondary outcome
Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
Time frame: Day 0 to Day 360 (V01 [Implantation] to V11)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32499329Mansouri K, Gillmann K, Rao HL, Weinreb RN; ARGOS-2 Study Group. Weekly and seasonal changes of intraocular pressure measured with an implanted intraocular telemetry sensor. Br J Ophthalmol. 2021 Mar;105(3):387-391. doi: 10.1136/bjophthalmol-2020-315970. Epub 2020 Jun 4.
- Telemetric Measurement of Intraocular Pressure via an Implantable Pressure Sensor-12-Month Results from the ARGOS-02 TrialLink provided by the sponsor.
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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.
Hagen Thieme, Prof. principal investigator
University Eye Clinic Magdeburg, Germany
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARGOS-IO system in people with Primary Open Angle Glaucoma (POAG), run by Implandata Ophthalmic Products GmbH at 11 sites in Germany.
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 11 inclusion and 27 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 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. 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 12 Dec 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?
Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation (time frame: Day 0 to Day 360 (V01 [Implantation] to V11)). The study lists 2 primary outcomes in all. 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 NCT02434692, 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 12 Dec 2024.