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

Primary Purpose

Glaucoma, Open-Angle

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Interposition supraciliary implant

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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
Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, …)
Medical treatment having intraocular hypotensive effect

Sites / Locations

Hopital Paris Saint Joseph

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

NCT ID

NCT03736655

First Posted

November 6, 2018

Last Updated

December 3, 2021

Sponsor

Ciliatech

1. Study Identification

Unique Protocol Identification Number

NCT03736655

Brief Title

Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

Acronym

SAFARI

Official Title

Non Randomised Multi-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

December 2021

Overall Recruitment Status

Terminated

Why Stopped

COVID

Study Start Date

March 15, 2019 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

October 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ciliatech

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of a 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

68 patients will be included in this 5 years 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 an interposition supraciliary permanent device. 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

27 (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 an 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

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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 Non surgical interventional treatment (cyclophotocoagulation, ultrasounds, …) Medical treatment having intraocular hypotensive effect

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe SOURDILLE

Organizational Affiliation

Ciliatech

Official's Role

Study Director

Facility Information:

Facility Name

Hopital Paris Saint Joseph

City

Paris

ZIP/Postal Code

75014

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma

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