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Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma (SAFARI 3)

Primary Purpose

Glaucoma, Open-Angle

Status

Active

Phase

Not Applicable

Locations

Armenia

Study Type

Interventional

Intervention

Interposition supraciliary implant

About this trial

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

Eligibility Criteria

18 Years - undefined (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
naive of any glaucoma surgery

Sites / Locations

Malayan center

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 >= 20% decrease in mean-Diurnal-IOP from baseline

Secondary Outcome Measures

Compare efficacy outcomes between POAG and PNAG sub-groups

Absolute differences in IOP

Full Information

NCT ID

NCT05236439

First Posted

February 2, 2022

Last Updated

March 14, 2023

Sponsor

Ciliatech

1. Study Identification

Unique Protocol Identification Number

NCT05236439

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 1, 2022 (Actual)

Primary Completion Date

September 30, 2023 (Anticipated)

Study Completion Date

March 31, 2026 (Anticipated)

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

5. 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) and primary narrow angle glaucoma (PNAG) who have failed at least one class of topical medical therapy

Detailed 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.

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

57 (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 SV22 interposition supraciliary implant in the supraciliary space

Primary Outcome Measure Information:

Title

Assess post-op IOP reduction

Description

Proportion of eyes with >= 20% decrease in mean-Diurnal-IOP from baseline

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Compare efficacy outcomes between POAG and PNAG sub-groups

Description

Absolute differences in IOP

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lilit Voskanyan

Organizational Affiliation

Malayan Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Malayan center

City

Yerevan

Country

Armenia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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