Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery

NCT05625958 | Active Not Recruiting DMC

• 1 other identifier: SAFARI 4
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 5

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 and narrow angle glaucoma 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 reduction

  Mean change in medicated IOP and IOP-lowering pharmacological treatments from baseline and 6 months after surgery

  6 months

Secondary Outcomes (24)

• Change in medicated IOP and IOP-lowering treatments

  baseline and 12, 24, and 26 months after surgery

• Decrease in IOP from baseline up to 36 months post-operatively

  baseline up to 6, 12, 24, and 36 months post-operatively

• Mean medicated IOP

  baseline, 6, 12, 24, and 36 months after surgery

• Mean number of IOP lowering treatments

  baseline, 6, 12, 24, and 36 months after surgery

• Absolute success rate: proportion of med-free eyes

  6, 12, 24, and 36 months

Study Arms (1)

Cilioscleral Interposition Device

EXPERIMENTAL

Any patients corresponding to inclusion / exclusion criteria

Device: Cilioscleral Interposition Device

Interventions

Cilioscleral Interposition Device DEVICE

Surgical placement of SV22 cilioscleral interposition device in the supraciliary space

Cilioscleral Interposition Device

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,
• To comply with all study requirements, including required study follow-up visits' agenda
• Eye:
• Glaucoma (angle from 1 to 4 according to Schaffer grade), 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 with -15 \< MD \< 0dB (Humphrey) or 0 \< MD \< 15 dB (Octopus)
• Pharmacological treatments: glaucoma not adequately controlled by 1 to 3 different IOP-lowering medication(s), given each for at least one month prior to Screening,
• IOP:
• if using 1 or 2 IOP-lowering medications, IOP is between 18 mmHg and 30 mmHg in the study eye at Screening visit
• if using 3 IOP-lowering medications, IOP is between 18 mmHg and 25 mmHg in the study eye at Screening visit
• Having the indication for glaucoma surgery alone (no concomitant cataract surgery)

You may not qualify if:

• 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)
• Fast progressing or very severe glaucoma or any condition requiring a filtering surgery
• 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
• Eye with uncontrolled IOP despite 4 IOP-lowering medications prescribed for more than a month
• Eye with severe OSD and / or severe dry eye defined as Oxford score ≥ 4

Sponsors & Collaborators

• Ciliatech: lead

Study Sites (5)

Hospital Clínic of Barcelona

Barcelona, 08028, Spain

Location

Hospital Clínico San Carlos. Servicio de Oftalmología

Madrid, 28040, Spain

Location

OMIQ Research

Sabadell, 08205, Spain

Location

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

Hospital Universitario Miguel Servet. Servicio de Oftalmología.

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Julian GARCIA FEIJOO, Pr

  Clinica San Carlos

  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: November 15, 2022
• First Posted: November 23, 2022
• Study Start: March 23, 2023
• Primary Completion: April 29, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)