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

Primary Purpose

Glaucoma, Open-Angle, Glaucoma, Narrow Angle

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cilioscleral Interposition Device
Sponsored by
Ciliatech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Cilioscleral Interposition Device

    Arm Description

    Any patients corresponding to inclusion / exclusion criteria

    Outcomes

    Primary Outcome Measures

    Assess post-op IOP reduction
    Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2022
    Last Updated
    February 10, 2023
    Sponsor
    Ciliatech
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05625958
    Brief Title
    Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery
    Acronym
    SAFARI4
    Official Title
    Multicentre, Non-randomised Clinical Study Evaluating the Efficacy and Safety of Cilioscleral Interposition Device v2.2 in Glaucoma Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    June 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ciliatech

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Open-Angle, Glaucoma, Narrow Angle

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cilioscleral Interposition Device
    Arm Type
    Experimental
    Arm Description
    Any patients corresponding to inclusion / exclusion criteria
    Intervention Type
    Device
    Intervention Name(s)
    Cilioscleral Interposition Device
    Intervention Description
    Surgical placement of SV22 cilioscleral interposition device in the supraciliary space
    Primary Outcome Measure Information:
    Title
    Assess post-op IOP reduction
    Description
    Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Olivier BENOIT
    Phone
    +33635550153
    Email
    o.benoit@cilia.tech
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julian GARCIA FEIJOO, Pr
    Organizational Affiliation
    Clinica San Carlos
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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