NCT03624361

Brief Summary

The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2021

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1.6 years

First QC Date

May 28, 2018

Last Update Submit

August 8, 2022

Conditions

Glaucoma, Open-AngleGlaucoma EyeIntraocular Pressure

Keywords

Minimally Invasive Glaucoma SurgeryGlaucoma ImplantLower IOPIOPIntraocular Pressure

Outcome Measures

Primary Outcomes (1)

  • Qualified success for lowering the IOP

    The primary objective is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21 mmHg and \> 5 mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery

    at 6 months

Secondary Outcomes (1)

  • Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study

    up to 24 months after surgery

Study Arms (1)

Stand-alone

EXPERIMENTAL

Patients will receive MINIject Glaucoma implant in a stand-alone procedure. MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.

Device: Glaucoma device implantation in a stand-alone procedure

Interventions

Glaucoma device implantation in a stand-alone procedureDEVICE

MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.

Stand-alone

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, 50 years of age or older.
  • Diagnosis of primary open angle glaucoma during screening visit or earlier.
  • Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.

You may not qualify if:

  • Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye.
  • Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System.
  • Neovascular glaucoma in the study eye.
  • Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Center Hospotalier Universitaire Genoble Alpes

Grenoble, 38043, France

Location

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Ludwig-Maximilians-University Munich

Munich, Bavaria, 80336, Germany

Location

Uni-Augenklinik Bochum

Bochum, North Rhine-Westphalia, 44892, Germany

Location

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Related Publications (1)

  • Garcia Feijoo J, Denis P, Hirneiss C, Aptel F, Perucho Gonzalez L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.

    PMID: 32769736RESULT

Related Links

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Officials

  • Norbert Pfeiffer, Prof.

    Universitätsklinikum Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: MINIject glaucoma implant CS600 with Dual Operator Delivery Tool
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

August 10, 2018

Study Start

May 23, 2018

Primary Completion

December 31, 2019

Study Completion

September 23, 2021

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

DE(5)FR(2)ES(1)