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NCT05236439 Clinical Trial

Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma

Glaucoma, Open-Angle Clinical Trial

— SAFARI 3  

Official title:
Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Cilioscleral Interposition Device (CID) SV22 in Glaucoma Patients Refractory to Topical Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05236439
Other study ID # SAFARI 3
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date March 31, 2026

Study information
Verified date February 2023
Source Ciliatech
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 angle glaucoma (POAG) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy

Description:

57 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 57
Est. completion date March 31, 2026
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of Primary Glaucome Schafer 1 to 4 - Medicated IOP = 21 - naive of any glaucoma surgery Exclusion Criteria: - Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Interposition supraciliary implant
Surgical placement of SV22 interposition supraciliary implant in the supraciliary space

Locations
Country Name City State
Armenia Malayan center Yerevan

Sponsors (1)
Lead Sponsor Collaborator
Ciliatech

Country where clinical trial is conducted

Armenia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess post-op IOP reduction Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline 6 months
Secondary Compare efficacy outcomes between POAG and PNAG sub-groups Absolute differences in IOP 6 months
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