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