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

Not Applicable

Terminated

• Conditions: Glaucoma, Open-Angle

• Registration Number: NCT04770324
• Lead Sponsor: Ciliatech

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

Detailed Description

22 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 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 Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-25
• Study Start: 2021-04-23
• Primary Completion: 2024-07-26
• Study Completion: 2024-07-26
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Assess post-op IOP reduction	6, 12, 24, 26, 48, 60 months	Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Assess post-op IOP clinical success	6, 12, 24, 26, 48, 60 months	Proportion of Eyes With Intraocular Pressure (IOP) \< 21 mmHg

Secondary Outcome Measures

Name	Time	Method
assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold	Up to 60 months	To describe the rate of patients with a post-operative IOP ≤ 18 mm Hg; as well as for a threshold ≤ 16 mm Hg
assess the rate of patients with no filtering bleb	Up to 60 months	To describe the rate of patients with no filtering bleb
Average number of adjunctive therapies and follow up visits	Up to 60 months	To describe the average number of adjunctive therapies (needling, goniopuncture) and follow up visits (including those which were scheduled and which were not scheduled in the protocol)
Evaluate surgical procedure	Day 0, day of surgery	To evaluate the surgical procedure (duration of operation, ease of implantation)
Evaluate implant and surgical procedure safety	up to 60 months	To evaluate the safety of the implant and the surgical procedure: To describe of all adverse events (AEs) throughout the study
Compare clinical success rate	Up to 60 months	To compare the clinical success rate at 6, 12, 24, 36, 48 and 60 months to that of the Supraflow study in Armenia
assess rate of patients with a reduction in post-op IOP with or without combined treatments	Up to 60 months	To describe the rate of patients with at least a 20%, 25%, 30% and 40% reduction in postoperative IOP, with or without combined medical treatments, at each visit
assess the mean and median reduction in IOP	Up to 60 months	To describe the mean and median reduction in IOP between the baseline and each subsequent assessment
assess the rate of patients without medical treatment for glaucoma	Up to 60 months	To describe the rate of patients without medical treatment for glaucoma at each visit
average rate of IOP reduction	Up to 60 months	describe the average rate of IOP reduction vs baseline
assess the rate of patients with a reduction of IOP post-operatively	Up to 60 months	To describe the rate of patients with a reduction of post-operative IOP of least 5 mmHg
assess IOP stability	Up to 60 months	To describe IOP stability over at each visit, without further eye surgery, and without the use of anti-glaucoma or adjunctive therapies such as goniopuncture or needling
Assess patient satisfaction	Up to 60 months	To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity
Assess changes in quality of life	Up to 60 months	To describe changes in quality of life (EQ5D)
Follow the progression of glaucoma and potential complications	Up to 60 months	To describe the progression of the glaucoma at 6, 12, 24, 36, 48 and 60 months, and any complications

Trial Locations

Locations (1)

Malayan Center; 🇦🇲 Yerevan, Armenia