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

NCT05236439 | Completed DMC

• 1 other identifier: SAFARI 3
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Conditions

Glaucoma, Open-Angle; Glaucoma, Narrow Angle

Outcome Measures

Primary Outcomes (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

  24 months

Secondary Outcomes (23)

• Assess post op mean diurnal IOP

  up to 36 months

• Assess mean medicated IOP

  Up to 36 months

• Mean number of IOP lowering pharmacological treatments

  Up to 36 months

• Mean change in post op IOP and IOP lowering pharmacological treatment

  6, 12, 18, and 36 months

• Assess absolute success rate

  Up to 36 months

Study Arms (1)

Interposition supraciliary implant

EXPERIMENTAL

Any patients corresponding to inclusion / exclusion criteria

Device: Interposition supraciliary implant

Interventions

Interposition supraciliary implant DEVICE

Surgical placement of SV22 interposition supraciliary implant in the supraciliary space

Interposition supraciliary implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient:
• 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
• 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

You may not qualify if:

• 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, …)
• 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, …)
• 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

Sponsors & Collaborators

• Ciliatech: lead
• Clinchoice Inc: collaborator

Study Sites (1)

Malayan center

Yerevan, Yerevan, Armenia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Lilit Voskanyan

  Malayan Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: May 23, 2022
• Primary Completion: February 19, 2025
• Study Completion: November 3, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)