Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)

Sponsor

Ciliatech (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04770324

Collaborator

(none)

Enrollment

Location

Arm

37.5

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 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 in Glaucoma Patients Refractory to Topical Therapy

Actual Study Start Date :

Feb 15, 2021

Actual Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interposition supraciliary implant Any patients corresponding to inclusion / exclusion criteria	Device: Interposition supraciliary implant Surgical placement of 2 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 2 interposition supraciliary implant in the supraciliary space

Outcome Measures

Primary Outcome Measures

Assess post-op IOP reduction [6 months]
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Assess post-op IOP clinical success [6 months]
Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malayan Center	Yerevan		Armenia	0033

Sponsors and Collaborators

Ciliatech

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ciliatech

ClinicalTrials.gov Identifier:

NCT04770324

Other Study ID Numbers:

SAFARI 2

First Posted:

Feb 25, 2021

Last Update Posted:

Dec 20, 2021

Last Verified:

Dec 1, 2021

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 Dec 20, 2021