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

Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of Supraflow v2.2 in Glaucoma Surgery

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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Armenia
  • Yerevan
    • Yerevan, Yerevan, Armenia
      • Malayan center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

To be included in the study, all patients must meet all the following inclusion criteria:

Patient:

1. 18 years or older
2. Able to understand study requirements

3. Able and willing:

   To provide written consent on the EC-approved Informed Consent Form, b. To comply with all study requirements, including required study follow-up visits' agenda

   Eye:

4. Primary Open Angle Glaucoma (POAG) or Narrow Angle Glaucoma (PNAG), including pseudo exfoliative and pigmentary glaucoma, which meets the following:

   1. Vertical C/D ratio on fundoscopic exam ≤ 0.9, or OCT demonstrating a thinness of the nerve fibre layer at the p<5% level as defined by the instrument's built in age-adjusted normative database,
   2. Glaucoma visual field (Humphrey) with -15 < MD < 0dB
5. Pharmacological treatments: glaucoma not adequately controlled by 1 to 4 different IOP-lowering medication(s), given each for at least one month prior to Screening,
6. IOP: if using 1 to 4 IOP-lowering medication, IOP is between 21 mmHg and 35 mmHg in the study eye at Screening and Baseline visits
7. Having the indication for glaucoma surgery alone (no concomitant cataract surgery)
8. Central Corneal Thickness between 480 to 620 µm
9. Gonioscopy confirming normal angle anatomy at site of implantation

Exclusion criteria

Patients will not participate in this clinical study if they meet any of the following criteria:

Patient:

1. Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder
2. Patient already included in another study
3. A person protected by law (temporary or permanent guardianship) or not capable of discernment
4. Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …)
5. Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening)
6. With uncontrolled systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits (e.g. inability to reliably complete visual field testing over the course of the study, or take glaucoma medications (e.g. Parkinson's disease), or uncontrolled systemic disease (diabetes, hypertension) that could compromise participation in the study, …)
7. Who have a new or modified prescription for a systemic treatment that could influence IOP within one month prior to inclusion, or who are aware of a future change in their systemic treatment, or if their medical condition indicates that their systemic treatment may change in the future

8. Chemotherapy in the last 6 months before surgery

   Eye:

9. Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
10. History of any incisional glaucoma surgery or implantable glaucoma device
11. Prior SLT, ALT or MLT
12. Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma
13. Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology)
14. Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease
15. Any known ocular condition that may require intraocular intervention during the protocol required follow-up period
16. Premature or mature cataract (initial cataract are accepted)
17. Any condition that prevents the investigational device implantation in the superior and nasal region of the eye
18. Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications
19. Non laser retinal surgery
20. Previous cyclodestructive or scleral buckling procedure
21. History of complicated cataract surgery (as posterior capsular rupture, vitreous loss)
22. History of silicone oil
23. Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery
24. Use of oral hypotensive glaucoma medications for treatment of the fellow eye
25. Axial length <20 mm
26. Severe myopia
27. Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye
28. Peripheral synechia at the angle
29. Closed angle
30. Peripheral laser iridotomy in the last 7 days before planned surgery
31. Epithelial or fibrous downgrowth
32. Severe dry eye syndrome
33. Severe blepharitis
34. Chronic or recurrent uveitis
35. Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation
36. Active iris neovascularization, rubeosis, proliferative retinopathy, diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders), vitreous haemorrhage, preretinal haemorrhage, choroidopathy or other ophthalmic disease that could confound study results
37. Scleral fixation IOL
38. Lens dislocation or subluxation
39. Vitreous loss in the anterior chamber

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 SV22 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 and IOP lowering pharmacological treatments	Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 24 months after surgery	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess post op mean diurnal IOP	Proportion of eyes with ≥ 20% decrease in mean-Diurnal-IOP from baseline up to 6, 12, 18, 24 and 36 months post-operatively with IOP lowering medication	up to 36 months
Assess mean medicated IOP	Mean medicated IOP at Baseline and 6, 12, 18, 24 and 36 months after surgery	Up to 36 months
Mean number of IOP lowering pharmacological treatments	Mean number of IOP-lowering pharmacological treatments at baseline and 6, 12, 18, 24 and 36 months after surgery	Up to 36 months
Mean change in post op IOP and IOP lowering pharmacological treatment	Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline at 6, 12, 18 and 36 months after surgery	6, 12, 18, and 36 months
Assess absolute success rate	Absolute success rate: proportion of med-free eyes with ≥ 20% decrease from baseline and below 18 mmHg at 6, 12, 18, 24 and 36 months after surgery	Up to 36 months
Assess qualified success rate	Qualified success rate: proportion of eyes with ≥ 20% decrease from baseline and below 18 mmHg at 6, 12, 18, 24 and 36 months after surgery	Up to 36 months
Rate of patients with a reduction in post operative IOP	Rate of patients with at least a 20%, 30%, 40% and more than 50% reduction in post operative IOP, with or without combined medical treatments, at each visit	Up to 36 months
Proportion of eyes free of ocular hypotensive medications	Proportion of eyes free of ocular hypotensive medications at 6, 12, 18, 24 and 36 months after surgery	Up to 36 months
Assess proportion of eyes with IOP between 6-18 mmHg	Proportion of eyes with IOP ≥6 mmHg and ≤ 18 mmHg, the same with med-free eyes only	Up to 36 months
Proportion of eyes with IOP between 6-16 mmHg	Proportion of eyes with IOP ≥6 mmHg and ≤ 16 mmHg, the same with med-free eyes only	Up to 36 months
Average number of adjunctive therapies post-operatively	Average number of adjunctive therapies (needling, goniopuncture, SLT, …) performed up to 36 months postoperatively	Up to 36 months
Rate of patients with no filtering blebs	Rate of patients with no filtering bleb, average duration of filtering blebs	Up to 36 months
Assess the surgical procedure	To evaluate the surgical procedure (duration of operation, ease of implantation)	Day 0, day of surgery
Assess patient satisfaction post-operatively	To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity	Up to 36 months
Describe patient's quality of life	To describe changes in quality of life (EQ5D)	Up to 36 months
Assess rate of intraoperative and post-operative related adverse device effects	Rate of intraoperative and post-operative device related ocular adverse events and adverse device effect	Up to 36 months
Review slit lamp, gonioscopy and fundus findings	Slit lamp, gonioscopy and fundus findings	Up to 36 months
Determine rate of BCVA	Rate of best corrected visual acuity variation (BCVA)	Up to 36 months
Assess rate of Visual field mean deviation variation (VF MD)	Rate of Visual field mean deviation variation (VF MD)	Up to 36 months
Determine rate of C/D ratio mean deviation	Rate of C/D ratio mean deviation	Up to 36 months
Assess rate of sight threatening events	Rate of sight threatening events	Up to 36 months
Assess rate of change in endothelial cell density and central corneal thickness	Rate of change in endothelial cell density (ECD) and central corneal thickness (CCT)	Up to 36 months
Assess rate of occurrence of SV22 movements in the supraciliary space	Rate of occurrence of SV22 movements inside the supraciliary space (SCS), defined as a change of position of the anterior edge of the implant of at least 200 µm measured on UBM from D7 to any timepoint	Up to 36 months

Collaborators and Investigators

• Sponsor: Ciliatech
• Collaborators: Clinchoice Inc
• Investigators: Principal Investigator: Lilit Voskanyan, Malayan center

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2022
• Primary Completion (Actual): February 19, 2025
• Study Completion (Actual): November 3, 2025

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure
• Other Study ID Numbers: SAFARI 3

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
• product manufactured in and exported from the U.S.: No