Back to resultsStudy of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2) (SAFARI 2)
Primary Purpose
Glaucoma, Open-Angle
Status
Active
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
Interposition supraciliary implant
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle
Eligibility Criteria
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
Sites / Locations
- Malayan Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interposition supraciliary implant
Arm Description
Any patients corresponding to inclusion / exclusion criteria
Outcomes
Primary Outcome Measures
Assess post-op IOP reduction
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Assess post-op IOP clinical success
Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04770324
Brief Title
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)
Acronym
SAFARI 2
Official Title
Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant in Glaucoma Patients Refractory to Topical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
March 31, 2024 (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
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of implanting 2 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
Detailed Description
20 patients will be included in this 6 months 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 2 interposition supraciliary permanent devices.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-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
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interposition supraciliary implant
Arm Type
Experimental
Arm Description
Any patients corresponding to inclusion / exclusion criteria
Intervention Type
Device
Intervention Name(s)
Interposition supraciliary implant
Intervention Description
Surgical placement of 2 interposition supraciliary implant in the supraciliary space
Primary Outcome Measure Information:
Title
Assess post-op IOP reduction
Description
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Time Frame
6 months
Title
Assess post-op IOP clinical success
Description
Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Malayan Center
City
Yerevan
ZIP/Postal Code
0033
Country
Armenia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)
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