NCT04524416 MINIject Global Long-Term Follow-up Study
| NCT ID | NCT04524416 |
| Status | Recruiting |
| Phase | — |
| Sponsor | iSTAR Medical |
| Condition | Open Angle Glaucoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-08-05 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-08-05 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.
Eligibility Criteria
Inclusion Criteria: * Patient who received a MINIject glaucoma implant within a prior clinical study * Patient continues to have MINIject implanted at the point of enrolment * Patient must provide written informed consent to participate Exclusion Criteria: * Individuals under tutorship or trusteeship * Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol
Contact & Investigator
Zubair Hussain, PhD
STUDY DIRECTOR
iSTAR Medical
Frequently Asked Questions
Who can join the NCT04524416 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Open Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04524416 currently recruiting?
Yes, NCT04524416 is actively recruiting participants. Contact the research team at esma.islamaj@istarmed.com for enrollment information.
Where is the NCT04524416 trial being conducted?
This trial is being conducted at Barranquilla, Colombia, Grenoble, France, Lyon, France, Cologne, Germany and 5 additional locations.
Who is sponsoring the NCT04524416 clinical trial?
NCT04524416 is sponsored by iSTAR Medical. The principal investigator is Zubair Hussain, PhD at iSTAR Medical. The trial plans to enroll 300 participants.