GlaucomaPhase 1eV-SENNCT07480603
Pilot Study on a New Self Adjustable Glaucoma Drainage Device
A Phase 1 study testing eyeValve in people with Glaucoma, run by Rheon Medical SA at 1 site in Senegal.
Trial summary
A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- eyeValve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSenegal
- Study dates
- 1 Jun 2025to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 90 years.
- Diagnosis of primary open-angle glaucoma meeting the following criteria:
- Intraocular pressure (IOP) not controlled by at least one (1) or more classes of topical IOP-lowering medications, and
- Eye without visual acuity.
- Patients must be able to understand the study requirements and provide written informed consent.
- Patients must be willing to follow study instructions, agree to comply with all study procedures, and be able to attend all scheduled follow-up visits for at least 6 months after surgery.
Who cannot join
- Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breastfeeding, or inability to understand or provide informed consent.
- Pregnant or breastfeeding women, or women of childbearing potential who are not willing to use a medically acceptable method of contraception from the screening visit until the 12-month follow-up visit.
- Known or suspected allergy or hypersensitivity to any component of the device (e.g., silicone).
- Current participation, or participation within the last 30 days (from the screening visit), in another investigational drug or interventional device clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study eyeValve
A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed.
- Conditions
- Glaucoma
- Being tested
- eyeValve
- Keywords
- glaucoma, drainage device, filtering surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyeValveDevice
Implantation of a self adjustable glaucoma drainage device
| Study group | Role | What they receive |
|---|---|---|
| eyeValve | Experimental | Patient treated with the device Receives: Device: eyeValve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Type and rate of complications post-surgery
Measured: 3 months
IOP reduction
IOP reduction by >20%
Measured: Baseline versus every visit, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jun 2025
- Primary completion1 Sep 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rheon Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480603
- Sponsor's protocol ID
- eV-7007
- Acronym
- eV-SEN
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rafiei S, Gerber JM, Bigler S, Villamarin A, Stergiopulos C, Ndoye C, Ngom EM, Mermoud A, Stergiopulos N. First-in-human implantation of a self-adjustable glaucoma drainage device (eyeValve): safety and performance in blind eyes. Graefes Arch Clin Exp Ophthalmol. 2026 May 29. doi: 10.1007/s00417-026-07278-1. Online ahead of print.
PubMed 42213132
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study eyeValve
- ClinicalTrials.gov ID
- NCT07480603
- Acronym / sponsor ID
- eV-SEN / eV-7007
- Conditions
- Glaucoma
- Keywords
- glaucoma, drainage device, filtering surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Rheon Medical SAIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Mar 2026 (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.
A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eyeValve | Experimental | Device: eyeValvePatient treated with the device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18 to 90 years.
- Intraocular pressure (IOP) not controlled by at least one (1) or more classes of topical IOP-lowering medications, and
- Eye without visual acuity.
- Patients must be able to understand the study requirements and provide written informed consent.
- Patients must be willing to follow study instructions, agree to comply with all study procedures, and be able to attend all scheduled follow-up visits for at least 6 months after surgery.
Key exclusion criteria (4 listed)
- Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breastfeeding, or inability to understand or provide informed consent.
- Pregnant or breastfeeding women, or women of childbearing potential who are not willing to use a medically acceptable method of contraception from the screening visit until the 12-month follow-up visit.
- Known or suspected allergy or hypersensitivity to any component of the device (e.g., silicone).
- Current participation, or participation within the last 30 days (from the screening visit), in another investigational drug or interventional device clinical trial.
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 |
|---|---|---|
| eyeValveImplantation of a self adjustable glaucoma drainage device | Device | eyeValve |
Primary outcome
Safety
Time frame: 3 months
Type and rate of complications post-surgery
IOP reduction
Time frame: Baseline versus every visit, up to 1 year
IOP reduction by >20%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 42213132Rafiei S, Gerber JM, Bigler S, Villamarin A, Stergiopulos C, Ndoye C, Ngom EM, Mermoud A, Stergiopulos N. First-in-human implantation of a self-adjustable glaucoma drainage device (eyeValve): safety and performance in blind eyes. Graefes Arch Clin Exp Ophthalmol. 2026 May 29. doi: 10.1007/s00417-026-07278-1. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Not yet recruitingPhase 2
VGFTe-(HD)-OD-2566: Adjunctive Aflibercept Ahmed Glaucoma Valve (AAA) Study
Glaucoma
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Recruiting
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
Corneal Transplantation, Glaucoma
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 Phase 1 study testing eyeValve in people with Glaucoma, run by Rheon Medical SA at 1 site in Senegal.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 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 Senegal. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Safety (time frame: 3 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?
On the ClinicalTrials.gov record for NCT07480603, 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 18 Mar 2026.