Clinical trial NCT02434692: Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Keywords: Primary Open Angle Glaucoma
POAG
Glaucoma
Cataract
Surgery
Ocular Pressure
Lead sponsor: Implandata Ophthalmic Products GmbH
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Mentally competent and willing to provide written informed consent
2. 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.
3. 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)
4. Sufficiently controlled intraocular pressure (IOP)
5. Study eye needs to be phakic
6. Only one eye per patient may be implanted with the ARGOS-IO implant
7. 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.
8. Pre-operative anterior chamber depth (ACD) ≥2.0 mm as measured from the corneal endothelium
9. Axis length \>22 mm
10. Endothelial cell density of the cornea ≥2000 cells/mm²
11. Subjects able and willing to attend all scheduled visits and comply with all study procedures

Exclusion Criteria:

1. Any other type of glaucoma other than primary open-angle glaucoma as defined by inclusion criterion 3
2. 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.
3. Exudative age-related macular degeneration, instable macular degeneration 30 days prior to inclusion, or macular edema
4. Retinal detachment
5. Corneal diseases, especially diseases affecting the corneal endothelium, e.g. Fuchs' Dystrophia
6. Diabetes mellitus
7. Existence of Marfan-Syndrome, Ehlers-Danlos-Syndrome or Weill-Marchesani-Syndrome
8. 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
9. 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
10. History of eye tumor
11. 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)
12. Anterior chamber configuration that puts the subject at high risk to develop an angle closure glaucoma
13. History of extensive keloid formation
14. Severe dry eye syndrome
15. Subjects who will need to undergo ancillary procedures in the study eye at the time of implantation or during the post-operative study period
16. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, plaster or silicone (component of the device)
17. Existence of other active medical eye implant and/or other active medical implants in the head/neck region
18. 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
19. Severe generalized disease resulting in a life expectancy shorter than a year
20. Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
21. Currently pregnant or breastfeeding
22. 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
23. Patients who are not suitable for the study based on the surgeon's evaluation
24. Patients unable or unwilling to understand or comply with required study procedures
25. Patients with psychiatric disorders influencing their judgement or autonomy
26. 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.
27. Enrollment of the fellow eye in this clinical study

Primary outcomes:
measure: Safety: Number of Patients Experiencing a Device Related SAE (SADE) and Complications During Implantation
timeFrame: Day 0 to Day 360 (V01 [Implantation] to V11)
measure: Performance: Intraclass Correlation Between Intraocular Pressure (IOP) Measurements by GAT and the ARGOS-IO System
timeFrame: Day 30 to Day 360 (V05 to V11)
Secondary outcomes:
measure: Safety: Incidence, Nature, Severity & Seriousness of Observed AEs/ADEs.
timeFrame: Day 0 to Day 360 (V01 [Implantation] to V11)
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Augenklinik Universitätsklinikum Aachen
city: Ahaus
country: Germany
facility: Augen-Zentrum-Nordwest
city: Bochum
country: Germany
facility: Universitäts-Augenklinik Bochum
city: Düsseldorf
country: Germany
facility: Internationale Innovative Ophthalmochirurgie Breyer-Kaymak-Klabe
city: Heilbronn
country: Germany
facility: Augenklinik der SLK-Kliniken
city: Kiel
country: Germany
facility: nordBLICK Augenklinik Bellevue
city: Magdeburg
country: Germany
facility: Universitätsaugenklinik Magdeburg
city: Nürnberg
country: Germany
facility: Augenärztliches Augenchirurgisches Zentrum (AAZ)
city: Rostock
country: Germany
facility: Klinik und Poliklinik für Augenheilkunde der Universität Rostock
city: Sulzbach
country: Germany
facility: Knappschaftsklinikum Saar - Augenklinik
city: Tübingen
country: Germany
facility: Universitäts-Augenklinik
Study officials:
affiliation: University Eye Clinic Magdeburg, Germany
name: Hagen Thieme, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.