Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery (SAFARI4)

Multicentre, Non-randomised Clinical Study Evaluating the Efficacy and Safety of Cilioscleral Interposition Device v2.2 in Glaucoma Surgery

The purpose of this study is to evaluate the safety and effectiveness of implanting a new version of an interposition supraciliary implant (SV22) as a stand-alone therapy for lowering intraocular pressure (IOP) in patients with primary open and narrow angle glaucoma who have failed at least one class of topical medical therapy

Study Overview

• Status: Not yet recruiting
• Conditions: Glaucoma, Open-Angle; Glaucoma, Narrow Angle
• Intervention / Treatment: Device: Cilioscleral Interposition Device

Detailed Description

35 patients will be included in this 36 months interventional study.

All patients shall be indicated for glaucoma surgery alone (not combined with cataract), and will undergo incisional glaucoma therapy, including a simplified surgical technique allowing the placement of an interposition supraciliary permanent device.

Several patient data like safety events, 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 (Anticipated): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of POAG Schafer 1 to 4
• Medicated IOP ≥ 21
• naive of any prior glaucoma surgery

Exclusion Criteria:

• Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cilioscleral Interposition Device; Any patients corresponding to inclusion / exclusion criteria	Device: Cilioscleral Interposition Device; Surgical placement of SV22 cilioscleral interposition device 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 >= 20% decrease in mean-Diurnal-IOP from baseline	6 months

Collaborators and Investigators

• Sponsor: Ciliatech

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): October 1, 2023
• Study Completion (ANTICIPATED): June 1, 2026

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (ACTUAL): November 23, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure
• Other Study ID Numbers: SAFARI 4

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