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Glaucoma, Open-AngleSAFARI 3NCT05236439

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

A study testing Interposition supraciliary implant in people with Glaucoma, Open-Angle and Glaucoma, Narrow Angle, run by Ciliatech at 1 site in Armenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma, Open-Angle, Glaucoma, Narrow Angle
What is being tested?
Interposition supraciliary implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
1 siteArmenia
Study dates
23 May 2022to 3 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • To be included in the study, all patients must meet all the following inclusion criteria:
  • Patient:
  • 18 years or older
  • Able to understand study requirements
  • 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
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  • Eye:
  • Primary Open Angle Glaucoma (POAG) or Narrow Angle Glaucoma (PNAG), including pseudo exfoliative and pigmentary glaucoma, which meets the following:
  • 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,
  • Glaucoma visual field (Humphrey) with -15 < MD < 0dB
  • 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,
  • 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
  • Having the indication for glaucoma surgery alone (no concomitant cataract surgery)
  • Central Corneal Thickness between 480 to 620 µm
  • Gonioscopy confirming normal angle anatomy at site of implantation

Who cannot join

  • Patients will not participate in this clinical study if they meet any of the following criteria:
  • Patient:
  • Patient with a known allergy to any of the constituents of the products used in this study or known steroid responder
  • Patient already included in another study
  • A person protected by law (temporary or permanent guardianship) or not capable of discernment
  • Patient who may not assist to all follow-up visits (because of frequent travelling, or living in remote area, or limited moving capacities, …)
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  • Pregnant or nursing woman at the date of inclusion (only for women of childbearing potential: positive urine pregnancy test at screening)
  • 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, …)
  • 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
  • Chemotherapy in the last 6 months before surgery
  • Eye:
  • Inflammatory, congenital, malignant, traumatic, uveitic, neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
  • History of any incisional glaucoma surgery or implantable glaucoma device
  • Prior SLT, ALT or MLT
  • Eye surgery (other than glaucoma) less than 6 months ago, or presenting sequelae of previous eye surgery or trauma
  • Inability to obtain accurate IOP measurement throughout the study (e.g. history of corneal surgery, corneal opacities or disease/pathology)
  • Conditions associated with elevated episcleral venous pressure such as active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber syndrome, orbital tumors, orbital congestive disease
  • Any known ocular condition that may require intraocular intervention during the protocol required follow-up period
  • Premature or mature cataract (initial cataract are accepted)
  • Any condition that prevents the investigational device implantation in the superior and nasal region of the eye
  • Pre-existing ocular or systemic pathology that may, in the opinion of the Investigator, cause post-operative complications
  • Non laser retinal surgery
  • Previous cyclodestructive or scleral buckling procedure
  • History of complicated cataract surgery (as posterior capsular rupture, vitreous loss)
  • History of silicone oil
  • Ocular steroid in the planned study eye or systemic steroid use in the last 3 months before surgery
  • Use of oral hypotensive glaucoma medications for treatment of the fellow eye
  • Axial length <20 mm
  • Severe myopia
  • Best corrected distant visual acuity of 0.1 (20/200) or worse in the study or fellow eye
  • Peripheral synechia at the angle
  • Closed angle
  • Peripheral laser iridotomy in the last 7 days before planned surgery
  • Epithelial or fibrous downgrowth
  • Severe dry eye syndrome
  • Severe blepharitis
  • Chronic or recurrent uveitis
  • Conjunctiva showing keratitis, fine conjunctiva, erosion or abnormal vascularisation
  • 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
  • Scleral fixation IOL
  • Lens dislocation or subluxation
  • Vitreous loss in the anterior chamber

Trial locations and contacts

1 site in 1 country.

Armenia1 site

  • Malayan center

    Yerevan, Yerevan

Other trials in Armenia

About this study

Official title: 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

Read the 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.

Being tested
Interposition supraciliary implant
Medical subject headings
Glaucoma, Open-Angle, Glaucoma, Angle-Closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interposition supraciliary implantDevice

    Surgical placement of SV22 interposition supraciliary implant in the supraciliary space

Study groups in NCT05236439
Study groupRoleWhat they receive
Interposition supraciliary implantExperimentalAny patients corresponding to inclusion / exclusion criteria
Receives: Device: Interposition supraciliary implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

Secondary outcomes (23)

  1. 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

    Measured: up to 36 months

  2. Assess mean medicated IOP

    Mean medicated IOP at Baseline and 6, 12, 18, 24 and 36 months after surgery

    Measured: Up to 36 months

  3. 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

    Measured: Up to 36 months

  4. 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

    Measured: 6, 12, 18, and 36 months

  5. 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

    Measured: Up to 36 months

  6. 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

    Measured: Up to 36 months

  7. 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

    Measured: Up to 36 months

  8. 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

    Measured: Up to 36 months

  9. 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

    Measured: Up to 36 months

  10. 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

    Measured: Up to 36 months

  11. Average number of adjunctive therapies post-operatively

    Average number of adjunctive therapies (needling, goniopuncture, SLT, …) performed up to 36 months postoperatively

    Measured: Up to 36 months

  12. Rate of patients with no filtering blebs

    Rate of patients with no filtering bleb, average duration of filtering blebs

    Measured: Up to 36 months

  13. Assess the surgical procedure

    To evaluate the surgical procedure (duration of operation, ease of implantation)

    Measured: Day 0, day of surgery

  14. Assess patient satisfaction post-operatively

    To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity

    Measured: Up to 36 months

  15. Describe patient's quality of life

    To describe changes in quality of life (EQ5D)

    Measured: Up to 36 months

  16. 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

    Measured: Up to 36 months

  17. Review slit lamp, gonioscopy and fundus findings

    Slit lamp, gonioscopy and fundus findings

    Measured: Up to 36 months

  18. Determine rate of BCVA

    Rate of best corrected visual acuity variation (BCVA)

    Measured: Up to 36 months

  19. Assess rate of Visual field mean deviation variation (VF MD)

    Rate of Visual field mean deviation variation (VF MD)

    Measured: Up to 36 months

  20. Determine rate of C/D ratio mean deviation

    Rate of C/D ratio mean deviation

    Measured: Up to 36 months

  21. Assess rate of sight threatening events

    Rate of sight threatening events

    Measured: Up to 36 months

  22. 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)

    Measured: Up to 36 months

  23. 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

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study start23 May 2022
  3. Primary completion19 Feb 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236439
Sponsor's protocol ID
SAFARI 3
Acronym
SAFARI 3
Status last verified
Apr 2026
First submitted
2 Feb 2022
Last updated
24 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Voskanyan L, Papoyan V, Babayan H, Miroyan H, Baudouin C. A Prospective Evaluation of the 2-Year Efficacy and Safety of INTERCIL: A Novel Uveal Spacer for Open-Angle Glaucoma. Ophthalmol Ther. 2026 Aug 18. doi: 10.1007/s40123-026-01469-z. Online ahead of print.

    PubMed 42611171

Questions about this trial

What is this clinical trial studying?

A study testing Interposition supraciliary implant in people with Glaucoma, Open-Angle and Glaucoma, Narrow Angle, run by Ciliatech at 1 site in Armenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess post-op IOP and IOP lowering pharmacological treatments (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236439, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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