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

NCT04770324 | Terminated DMC

• 1 other identifier: SAFARI 2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (15)

• Evaluate implant and surgical procedure safety

  up to 60 months

• Compare clinical success rate

  Up to 60 months

• assess rate of patients with a reduction in post-op IOP with or without combined treatments

  Up to 60 months

• assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold

  Up to 60 months

• assess the rate of patients with a reduction of IOP post-operatively

  Up to 60 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 2 interposition supraciliary implant in the supraciliary space

Interposition supraciliary implant

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient:
• Patient ≥ 50 years old
• Patient dated and signed the informed consent form to participate in the study at first visit
• Eye:
• Phakic, pseudophakic or aphakic eye
• Has medically treated open-angle glaucoma (schaffer grade 3 and 4)
• 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
• Having undergone at most one filtration surgery (trabeculectomy, deep sclerectomy, viscocanalostomy) for more than 3 months.
• Having the indication for glaucoma surgery alone

You may not qualify if:

• Patient:
• Patient with a known allergy to any of the constituents of the products used in this study
• Patient already included in another study
• A person protected by law (temporary or permanent guardianship) or not capable of discernment
• Eye
• Presenting with inflammatory glaucoma
• Presenting with congenital glaucoma
• Presenting with major traumatic glaucoma or neovascular glaucoma or iridocorneal endothelial syndrome (ICE syndrome)
• Having had a non-surgical operational treatment (ultrasound, cyclophotocoagulation, etc.)
• Having had eye surgery (other than glaucoma) less than 6 months ago
• Closed angle, grade 1 or 2 Schafer OAG
• 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

Sponsors & Collaborators

• Ciliatech: lead
• Clinchoice Inc: collaborator

Study Sites (1)

Malayan Center

Yerevan, 0033, Armenia

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

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 23, 2021
• First Posted: February 25, 2021
• Study Start: April 23, 2021
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)