SAFARI 3: Study of an Interposition Supraciliary Implant SV22 in Patients With Primary Open Angle Glaucoma

Sponsor

Ciliatech (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05236439

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

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 angle glaucoma (POAG) who have failed at least one class of topical medical therapy

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle	Device: Interposition supraciliary implant	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Non Randomised Mono-centered Study to Evaluate Safety and Efficacy of a Novel Interposition Supraciliary Implant SV22 in Glaucoma Patients Refractory to Topical Therapy

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Aug 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interposition supraciliary implant Any patients corresponding to inclusion / exclusion criteria	Device: Interposition supraciliary implant Surgical placement of SV22 interposition supraciliary implant in the supraciliary space

Arm

Intervention/Treatment

Experimental: Interposition supraciliary implant

Any patients corresponding to inclusion / exclusion criteria

Device: Interposition supraciliary implant

Surgical placement of SV22 interposition supraciliary implant in the supraciliary space

Outcome Measures

Primary Outcome Measures

Assess post-op IOP reduction [12 months]
Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
naive of any glaucoma surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ciliatech

Investigators

Principal Investigator: Lilit Voskanyan, Malayan Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ciliatech

ClinicalTrials.gov Identifier:

NCT05236439

Other Study ID Numbers:

SAFARI 3

First Posted:

Feb 11, 2022

Last Update Posted:

Feb 11, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Glaucoma

Glaucoma, Open-Angle

Study Results

No Results Posted as of Feb 11, 2022