Glaucoma, Open-AngleSAFARI 2NCT04770324
Study of a Novel Interposition Supraciliary Implant in Patients With Open Angle Glaucoma (SAFARI 2)
A study testing Interposition supraciliary implant in people with Glaucoma, Open-Angle, run by Ciliatech at 1 site in Armenia.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Glaucoma, Open-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
- 22 participants
- Where
- 1 siteArmenia
- Study dates
- 23 Apr 2021to 26 Jul 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- Patient:
- Patient with visual acuity of the contralateral eye greater than LogMar 0.3. If no problems are detected at three months post surgery on at least the first 10 patients included, the study monitoring committee may propose to relax this non-inclusion criterion by setting the visual acuity of the contralateral eye above LogMar 0.7
- 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
Show all 21Show fewer
- 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
- Severe dry eye syndrome
- Severe blepharitis
- Retinopathy which can lead to neovascular complications in the anterior segment
- Eye of axial length <20 mm
- Eye with lens dislocation or subluxation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery
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
Read the detailed description
22 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 novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices.
Several patient data like 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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Interposition supraciliary implant
- Medical subject headings
- Glaucoma, Open-Angle
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 2 interposition supraciliary implant in the supraciliary space
| Study group | Role | What they receive |
|---|---|---|
| Interposition supraciliary implant | Experimental | Any 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.
Assess post-op IOP reduction
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Measured: 6, 12, 24, 26, 48, 60 months
Assess post-op IOP clinical success
Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg
Measured: 6, 12, 24, 26, 48, 60 months
Secondary outcomes (15)
Evaluate implant and surgical procedure safety
To evaluate the safety of the implant and the surgical procedure: To describe of all adverse events (AEs) throughout the study
Measured: up to 60 months
Compare clinical success rate
To compare the clinical success rate at 6, 12, 24, 36, 48 and 60 months to that of the Supraflow study in Armenia
Measured: Up to 60 months
assess rate of patients with a reduction in post-op IOP with or without combined treatments
To describe the rate of patients with at least a 20%, 25%, 30% and 40% reduction in postoperative IOP, with or without combined medical treatments, at each visit
Measured: Up to 60 months
assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold
To describe the rate of patients with a post-operative IOP ≤ 18 mm Hg; as well as for a threshold ≤ 16 mm Hg
Measured: Up to 60 months
assess the rate of patients with a reduction of IOP post-operatively
To describe the rate of patients with a reduction of post-operative IOP of least 5 mmHg
Measured: Up to 60 months
assess the mean and median reduction in IOP
To describe the mean and median reduction in IOP between the baseline and each subsequent assessment
Measured: Up to 60 months
assess the rate of patients without medical treatment for glaucoma
To describe the rate of patients without medical treatment for glaucoma at each visit
Measured: Up to 60 months
average rate of IOP reduction
describe the average rate of IOP reduction vs baseline
Measured: Up to 60 months
assess IOP stability
To describe IOP stability over at each visit, without further eye surgery, and without the use of anti-glaucoma or adjunctive therapies such as goniopuncture or needling
Measured: Up to 60 months
assess the rate of patients with no filtering bleb
To describe the rate of patients with no filtering bleb
Measured: Up to 60 months
Average number of adjunctive therapies and follow up visits
To describe the average number of adjunctive therapies (needling, goniopuncture) and follow up visits (including those which were scheduled and which were not scheduled in the protocol)
Measured: Up to 60 months
Evaluate surgical procedure
To evaluate the surgical procedure (duration of operation, ease of implantation)
Measured: Day 0, day of surgery
Assess patient satisfaction
To describe patient satisfaction following surgery based on criteria of pain, discomfort and deterioration in visual acuity
Measured: Up to 60 months
Assess changes in quality of life
To describe changes in quality of life (EQ5D)
Measured: Up to 60 months
Follow the progression of glaucoma and potential complications
To describe the progression of the glaucoma at 6, 12, 24, 36, 48 and 60 months, and any complications
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start23 Apr 2021
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Why it stopped: All original protocol assessments through M36 were completed. M48/60 were amendment additions to assess long-term efficacy. A new SV22 device was developed, and all subsequent studies used it. Amendments reflected interest in outcomes, not safety.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciliatech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinchoice Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770324
- Sponsor's protocol ID
- SAFARI 2
- Acronym
- SAFARI 2
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2021
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentre, Non-Randomised Clinical Study Evaluating the Efficacy and Safety of 2 Supraflow® v1.3 Medical Devices in Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT04770324
- Acronym / sponsor ID
- SAFARI 2 / SAFARI 2
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: All original protocol assessments through M36 were completed. M48/60 were amendment additions to assess long-term efficacy. A new SV22 device was developed, and all subsequent studies used it. Amendments reflected interest in outcomes, not safety.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- CiliatechIndustry (pharma, biotech, devices)
- Collaborators
- Clinchoice Inc
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
22 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 novel simplified surgical technique allowing placement of 2 interposition supraciliary permanent devices.
Several patient data like 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interposition supraciliary implant | Experimental | Device: Interposition supraciliary implantAny patients corresponding to inclusion / exclusion criteria |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient ≥ 50 years old
- Patient dated and signed the informed consent form to participate in the study at first visit
- 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
Key exclusion criteria (21 listed)
- Patient with visual acuity of the contralateral eye greater than LogMar 0.3. If no problems are detected at three months post surgery on at least the first 10 patients included, the study monitoring committee may propose to relax this non-inclusion criterion by setting the visual acuity of the contralateral eye above LogMar 0.7
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interposition supraciliary implantSurgical placement of 2 interposition supraciliary implant in the supraciliary space | Device | Interposition supraciliary implant |
Primary outcome
Assess post-op IOP reduction
Time frame: 6, 12, 24, 26, 48, 60 months
Proportion of Eyes With Intraocular Pressure (IOP) Reduction of ≥ 20%
Assess post-op IOP clinical success
Time frame: 6, 12, 24, 26, 48, 60 months
Proportion of Eyes With Intraocular Pressure (IOP) < 21 mmHg
15 secondary outcomes
Evaluate implant and surgical procedure safety
Time frame: up to 60 months
Compare clinical success rate
Time frame: Up to 60 months
assess rate of patients with a reduction in post-op IOP with or without combined treatments
Time frame: Up to 60 months
assess rate of patients with IOP less than or equal to 18 mmHg and less than or equal to threshold
Time frame: Up to 60 months
assess the rate of patients with a reduction of IOP post-operatively
Time frame: Up to 60 months
assess the mean and median reduction in IOP
Time frame: Up to 60 months
assess the rate of patients without medical treatment for glaucoma
Time frame: Up to 60 months
average rate of IOP reduction
Time frame: Up to 60 months
assess IOP stability
Time frame: Up to 60 months
assess the rate of patients with no filtering bleb
Time frame: Up to 60 months
Average number of adjunctive therapies and follow up visits
Time frame: Up to 60 months
Evaluate surgical procedure
Time frame: Day 0, day of surgery
Assess patient satisfaction
Time frame: Up to 60 months
Assess changes in quality of life
Time frame: Up to 60 months
Follow the progression of glaucoma and potential complications
Time frame: Up to 60 months
Results and safety
The study was stopped early (reason given: All original protocol assessments through M36 were completed. M48/60 were amendment additions to assess long-term efficacy. A new SV22 device was developed, and all subsequent studies used it. Amendments reflected interest in outcomes, not safety.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interposition supraciliary implant in people with Glaucoma, Open-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 9 inclusion and 21 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: stopped early, as of the sponsor's last update on 1 Oct 2025. 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 was stopped early (reason given: All original protocol assessments through M36 were completed. M48/60 were amendment additions to assess long-term efficacy. A new SV22 device was developed, and all subsequent studies used it. Amendments reflected interest in outcomes, not safety.). Results are not available in the source record.
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 reduction (time frame: 6, 12, 24, 26, 48, 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025; AzTrials last refreshed its copy on 7 Nov 2026.