Trial document




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  DRKS00012414

Trial Description

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Title

A Prospective Evaluation of Mild to Moderate Open-Angle
Glaucoma Subjects Treated with Second GenerationTrabecular Micro-bypass Stents and One Suprachoroidal Stent
A multicenter study according to MPG §23.b

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Trial Acronym

GCF-041

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URL of the Trial

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Brief Summary in Lay Language

Glaucoma might lead to blindness due to an increased intraocular pressure (IOP). Usually antigalucomatous eye drops are used for treatment. If these (also combinations of 2 or more agents) are not sufficient, a surgical intervention is indicated. A rather new method is the micro-invasive glaucoma surgery which allows for a safe and atraumatic implantation of so called bypass stents, i.e. small tubes which ab interno (no connection to the eye surface) lead to an improved aqueous outflow and an IOP reduction. The iStent inject is implanted into the trabecular meshwork, through which the aqueous is usually drained. The iStent bypasses the blocked tissue. In this study, patients with mild to moderate glaucoma (glaucomatous damage already present) will be implanted with 2 iStent inject The objective of this study is to evaluate, if a parallel implantation of an iStent supra (which is implanted in the suprachoroidal area and provides an additional aqueous outflow) provides a continuous IOP reduction over 24 months and if the patients need less medication. The IOP and the number of medication will be measured at several time points during the 24 month follow-up period and compared with the baseline values before and after washout of the medication.

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Brief Summary in Scientific Language

Evaluation of the intraocular pressure (IOP) lowering effect and safety of the additional implantation of an iStent supra in patients with mild or moderate glaucoma which are scheduled for implantation of 2 iStent inject.
The iStent inject (two trabecular micro-bypass stents) and one and a suprachoroidal iStent supra stent will be implanted into each study eye. The iStent inject is designed to create a patent bypass through the trabecular meshwork to Schlemm’s canal to restore physiologic aqueous outflow and continuously lower intraocular pressure. The iStent supra is designed to create a patent lumen from the anterior chamber into the suprachoroidal space intended to enhance uveoscleral outflow and reduce intraocular pressure.The study population will consist of 50 eyes of 50 subjects with mild-moderate open-angle glaucoma at up to 10 investigational sites. All subjects will be followed for 24 months with several time points at which IOD is measured and the number of medication is counted.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012414
  •   2017/05/08
  •   [---]*
  •   no
  •   Approved
  •   A 2016-0154, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

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Health Condition or Problem studied

  •   H40.1 -  Primary open-angle glaucoma
  •   H40.5 -  Glaucoma secondary to other eye disorders
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Interventions/Observational Groups

  •   Implantation of iStent inject (two trabecular micro-bypass stents) and a suprachoroidal iStent supra stent via a micro incision
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

≥ 20% Reduction in IOP at Month 12: A subject will be considered a responder if they meet all the criteria for the primary efficacy endpoint defined as:
•observed at the Month 12 visit,
•12-month mean diurnal IOP reduced by ≥ 20% vs. baseline mean diurnal IOP,
•no use of ocular hypotensive medication for ≥ 4 weeks immediately prior to the 12-month visit,
•no secondary surgical interventions to control IOP (e.g., laser trabeculoplasty, trabeculectomy, stent, shunt or valve placement) prior to the 12-month visit, and
•no postoperative procedure to reposition or remove stents prior to the 12-month visit

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Secondary Outcome

Month 12 IOP ≤ 18 mmHg: A subject will be considered a responder if they meet all the criteria for the secondary efficacy endpoint defined as:
•observed at the Month 12 visit,
•12-month mean diurnal IOP ≤ 18 mmHg
•no use of ocular hypotensive medication for ≥ 4 weeks immediately prior to the 12-month visit,
•no secondary surgical interventions to control IOP (e.g., laser trabeculoplasty, trabeculectomy, stent, shunt or valve placement) prior to the 12-month visit, and
•no postoperative procedure to reposition or remove stents prior to the 12-month visit

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • University Medical Center 
  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/05/31
  •   50
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Screening Exam Inclusion Criteria:
•Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
•Primary open-angle glaucoma or pseudoexfoliative glaucoma
•C/D ratio ≤ 0.9
•Visual field defects (with mean deviation no worse than – 12db), or nerve abnormality characteristic of glaucoma
•Subject on two topical ocular hypotensive medications
•Medicated IOP of ≥ 18 mmHg and ≤ 30 mmHg
•BCVA 20/80 or better
•Normal angle anatomy as determined by gonioscopy
•Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair placement of stents
•Able and willing to attend scheduled follow-up exams for 24 months postoperatively
•Able and willing to provide written informed consent on the approved Informed Consent Form

Baseline Exam Inclusion Criteria:
•Subject has completed appropriate medication washout
•Mean diurnal IOP ≥ 21 mmHg and ≤ 45 mmHg after washout of ocular hypotensive medications

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Exclusion Criteria

Screening Exam Exclusion Criteria:
•Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
•Prior stent implantation
•Prior ALT
•Prior SLT within 90 days of screening visit
•Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
•Functionally significant visual field loss, including severe nerve fiber bundle defects such as Bjerrum scotoma
•Ineligibility for ocular hypotensive medication washout period as determined by the investigator such as:
•visual field status would be placed at risk by washout period
•unmedicated IOP after washout period would be expected to exceed upper limit of 45 mmHg
•Any active corneal inflammation or edema (e.g., keratitis, keratoconjunctivitis, keratouveitis)
•Clinically significant corneal dystrophy (e.g., bullous keratopathy, Fuch’s dystrophy); any guttata
•Corneal surgery (prior or anticipated) of any type (including LASIK, LASEK, PRK, etc.) that may interfere with IOP measurement reliability
•Corneal opacities or disorders that would inhibit visualization of the nasal angle
•Congenital or traumatic cataract
•Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with the existing glaucoma condition
•Elevated episcleral venous pressure such as associated with:
oactive thyroid orbitopathy
ocavernous sinus fistula
oSturge-Weber syndrome
oorbital tumors
oorbital congestive disease
•Clinically significant sequelae from trauma (e.g., chemical burns, blunt trauma, etc.)
•Chronic ocular inflammatory disease or presence of active ocular inflammation (e.g., uveitis, iritis, iridocyclitis, retinitis)
•Any pathology for which, in the investigator’s judgment, the following would be either at risk or contraindicated:
•stent implantation
•compliance to elements of the study protocol (e.g., ophthalmic examinations, follow-up visits)
•Fellow eye BCVA worse than 20/200
•Fellow eye actively enrolled in this trial
•Concurrent participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the past 30 days.
• Pregant or lactating women

Baseline Exam Exclusion Criteria:
•Subject did not complete medication washout
•Mean IOP < 21 mmHg or > 45 mmHg after ocular hypotensive medication washout

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Addresses

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    • Glaukos Corp
    • Ms.  Dr.  Sally  Tucker 
    • 229 Avenida Fabricante
    • CA 92672  San Clemente
    • United States
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    • targomed GmbH
    • Ms.  Dr.  Monika  Fuchs 
    • Amalienstr. 2
    • 76646  Bruchsal
    • Germany
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    • Glaukos Corp
    • Ms.  Dr.  Sally  Tucker 
    • 229 Avenida Fabricante
    • CA 92672  San Clemente
    • United States
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    • Glaukos GmbH
    • Mr.  Dr.  Harald  Fuchs 
    • Gustav-Stresemann-Ring 1
    • 65189  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • Glaukos Corp
    • 229 Avenida Fabricante
    • CA 92672  San Clemente
    • United States
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Status

  •   Recruiting stopped after recruiting started
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.