Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI)

Non Randomised Multi-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy

The purpose of this study is to evaluate the safety and effectiveness of a novel interposition supraciliary implant as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Study Overview

• Status: Terminated
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: Interposition supraciliary implant

Detailed Description

68 patients will be included in this 5 years interventional study. All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a novel simplified surgical technique allowing placement of an interposition supraciliary permanent device.

Several patient data like IOP, visual capacity or associated pharmacological treatments will be recorded pre and post-operatively all along the follow-up.

Purpose is to ensure device safety, and verify IOP and associated pharmacological treatment reduction after surgery, and evolution along follow-up.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hôpital Paris Saint Joseph

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of POAG Schafer 3 or 4
• Medicated IOP ≥ 21

Exclusion Criteria:

• Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
• Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, …)
• Medical treatment having intraocular hypotensive effect

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interposition supraciliary implant; Any patients corresponding to inclusion / exclusion criteria	Device: Interposition supraciliary implant; Surgical placement of an interposition supraciliary implant in the supraciliary space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess post-op IOP reduction	Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%	6 months
Assess post-op IOP clinical success	Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg	6 months

Collaborators and Investigators

• Sponsor: Ciliatech
• Investigators: Study Director: Philippe SOURDILLE, Ciliatech

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2021
• Last Update Submitted That Met QC Criteria: December 3, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: CIV-FR-18-07-024848

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No