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

Sponsor

Ciliatech (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05625958

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 and narrow angle glaucoma who have failed at least one class of topical medical therapy

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Glaucoma, Narrow Angle	Device: Cilioscleral Interposition Device	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:

Multicentre, Non-randomised Clinical Study Evaluating the Efficacy and Safety of Cilioscleral Interposition Device v2.2 in Glaucoma Surgery

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Cilioscleral Interposition Device

Any patients corresponding to inclusion / exclusion criteria

Device: Cilioscleral Interposition Device

Surgical placement of SV22 cilioscleral interposition device 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 1 to 4
Medicated IOP ≥ 21

Exclusion Criteria:

Inflammatory, congenital, traumatic, neovascular, ICE syndrome, angle closure and Schaffer 1 and 2 glaucoma
naive of any prior glaucoma surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ciliatech

Investigators

Principal Investigator: Julian GARCIA FEIJOO, Pr, Clinica San Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ciliatech

ClinicalTrials.gov Identifier:

NCT05625958

Other Study ID Numbers:

SAFARI 4

First Posted:

Nov 23, 2022

Last Update Posted:

Nov 28, 2022

Last Verified:

Nov 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

Glaucoma, Angle-Closure

Study Results

No Results Posted as of Nov 28, 2022