NCT02272569

Brief Summary

Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
5 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

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

3.8 years

First QC Date

October 21, 2014

Last Update Submit

February 11, 2021

Conditions

Open Angle Glaucoma

Keywords

glaucomaglaucoma drainage deviceglaucoma shunt

Outcome Measures

Primary Outcomes (1)

  • Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP

    IOP of each patients at baseline will be compared to IOP of patient after 12 months

    12 months

Secondary Outcomes (9)

  • Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP

    24 months

  • Reduction in number of IOP lowering medications at 12 months vs. baseline

    12 months

  • Reduction in number of IOP lowering medications at 24 months vs. baseline

    24 months

  • Rate of adverse events

    24 months

  • Visual Acuity

    12 months

  • +4 more secondary outcomes

Study Arms (1)

STARflo Glaucoma Implant

EXPERIMENTAL

Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space

Device: STARflo Glaucoma Implant

Interventions

STARflo Glaucoma ImplantDEVICE

Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.

STARflo Glaucoma Implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of refractory open angle glaucoma
  • Documented 21 mmHg \< IOP ≤ 40 mmHg, under medication
  • Patient must provide written informed consent

You may not qualify if:

  • Patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye
  • Patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery
  • Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UZA

Edegem, 2650, Belgium

Location

CHU Sart Tilman

Liège, Belgium

Location

MHAT Central Onco Hospital

Plovdiv, Bulgaria

Location

Hopital de la Croix-Rousse

Lyon, 69417, France

Location

CHNO des Quinze Vingts

Paris, France

Location

University Clinic Heidelberg

Heidelberg, 69120, Germany

Location

Ludwig-Maximilians-University Munich

Munich, 80336, Germany

Location

Universitatsklinik fur Augenheilkunde Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Zubair Hussain, PhD

    Sponsor Representative

    STUDY CHAIR

  • Sheng Lim, Dr.

    Medical Advisor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

February 15, 2021

Record last verified: 2021-02

Locations

CH(1)FR(2)BE(2)BU(1)DE(2)