STARflo European Safety and Efficacy Study

Open Angle Glaucoma Clinical Trial

Official title:

A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02272569
• Other study ID #: ISM01
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 2019

Study information

• Verified date: February 2021
• Source: iSTAR Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant. Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation. When eligibility has been established using the in/exclusion criteria, surgery will be scheduled. Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

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

Main Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

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

Locations

Country	Name	City	State
Belgium	UZA	Edegem
Belgium	CHU Sart Tilman	Liège
Bulgaria	MHAT Central Onco Hospital	Plovdiv
France	Hopital de la Croix-Rousse	Lyon
France	CHNO des Quinze Vingts	Paris
Germany	University Clinic Heidelberg	Heidelberg
Germany	Ludwig-Maximilians-University Munich	Munich
Switzerland	Universitatsklinik fur Augenheilkunde Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Belgium,  Bulgaria,  France,  Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP	IOP of each patients at baseline will be compared to IOP of patient after 24 months	24 months
Secondary	Reduction in number of IOP lowering medications at 12 months vs. baseline	compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months	12 months
Secondary	Reduction in number of IOP lowering medications at 24 months vs. baseline	compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months	24 months
Secondary	Rate of adverse events	assessment and counting of adverse events (% by adverse event) including procedure related complications	24 months
Secondary	Visual Acuity	comparison of visual acuity at 12 months vs. baseline	12 months
Secondary	Absolute success rate (%) at 12 months	absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication	12 months
Secondary	Qualified success rate (%) at 12 months	qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication	12 months
Secondary	Qualified success rate (%) at 24 months	qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication	24 months
Secondary	Absolute success rate (%) at 24 months	absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication	24 months