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

Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery

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

Study Overview

• Status: Terminated
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: Interposition supraciliary implant

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia, 0033
    • Malayan center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

Patient:

1. Patient ≥ 50 years old

2. Patient dated and signed the informed consent form to participate in the study at first visit

   Eye:

3. Phakic, pseudophakic or aphakic eye
4. Has medically treated open-angle glaucoma (schaffer grade 3 and 4)
5. The optimal medical treatment against glaucoma for this eye has failed i. Preoperative treatment ≥ 2 molecules with target IOP not reached despite medication, ii. or IOP ≥ 21 mmHg under treatment, iii. or patient not compliant with treatment, iv. or patient intolerant to treatment
6. Having undergone at most one filtration surgery (trabeculectomy, deep sclerectomy, viscocanalostomy) for more than 3 months.
7. Having the indication for glaucoma surgery alone

Exclusion criteria

Patient:

1. Patient with visual acuity of the contralateral eye greater than LogMar 0.3. If no problems are detected at three months post surgery on at least the first 10 patients included, the study monitoring committee may propose to relax this non-inclusion criterion by setting the visual acuity of the contralateral eye above LogMar 0.7
2. Patient with a known allergy to any of the constituents of the products used in this study
3. Patient already included in another study

4. A person protected by law (temporary or permanent guardianship) or not capable of discernment

   Eye

5. Presenting with inflammatory glaucoma
6. Presenting with congenital glaucoma
7. Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
8. Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.)
9. Having had eye surgery (other than glaucoma) less than 6 months ago
10. Closed angle, grade 1 or 2 Schafer OAG

11. Pre-existing ocular or systemic pathology that may cause post operative complications such as:

    • Clinically significant inflammation such as uveitis
    • Eye infection
    • Anterior segment neovascular disease
12. Severe dry eye syndrome
13. Severe blepharitis
14. Retinopathy which can lead to neovascular complications in the anterior segment
15. Eye of axial length <20 mm
16. Eye with lens dislocation or subluxation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate implant and surgical procedure safety	To evaluate the safety of the implant and the surgical procedure: To describe of all adverse events (AEs) throughout the study	up to 60 months
Compare clinical success rate	To compare the clinical success rate at 6, 12, 24, 36, 48 and 60 months to that of the Supraflow study in Armenia	Up to 60 months
assess rate of patients with a reduction in post-op IOP with or without combined treatments	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	Up to 60 months
assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold	To describe the rate of patients with a post-operative IOP ≤ 18 mm Hg; as well as for a threshold ≤ 16 mm Hg	Up to 60 months
assess the rate of patients with a reduction of IOP post-operatively	To describe the rate of patients with a reduction of post-operative IOP of least 5 mmHg	Up to 60 months
assess the mean and median reduction in IOP	To describe the mean and median reduction in IOP between the baseline and each subsequent assessment	Up to 60 months
assess the rate of patients without medical treatment for glaucoma	To describe the rate of patients without medical treatment for glaucoma at each visit	Up to 60 months
average rate of IOP reduction	describe the average rate of IOP reduction vs baseline	Up to 60 months
assess IOP stability	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	Up to 60 months
assess the rate of patients with no filtering bleb	To describe the rate of patients with no filtering bleb	Up to 60 months
Average number of adjunctive therapies and follow up visits	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)	Up to 60 months
Evaluate surgical procedure	To evaluate the surgical procedure (duration of operation, ease of implantation)	Day 0, day of surgery
Assess patient satisfaction	To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity	Up to 60 months
Assess changes in quality of life	To describe changes in quality of life (EQ5D)	Up to 60 months
Follow the progression of glaucoma and potential complications	To describe the progression of the glaucoma at 6, 12, 24, 36, 48 and 60 months, and any complications	Up to 60 months

Collaborators and Investigators

• Sponsor: Ciliatech
• Collaborators: Clinchoice Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): July 26, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 26, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: SAFARI 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No