Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-… (NCT06321562) | Clinical Trial Compass
TerminatedPhase 1
Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma
Stopped: The study was terminated early due to the difficulties to enrol participant
Germany1 participantsStarted 2023-03-01
Plain-language summary
The purpose of this study is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma and pseudophakia (currently present or to be performed during the concomitant implantation surgery in subjects with age-related cataract eligible to intra-capsular IOL placement). The main questions it aims to answer are how safe the investigational drug is and how the body tolerates it.
The study will also check:
* how safely the implant is placed in and removed from the eye and how the body responds to the procedure,
* how safe different doses of timolol are and how the body handles taking it,
* the amount of Timolol released in the bloodstream,
* if there is any positive effect on the pressure inside the eye.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Capable of giving signed informed consent.
* In good general and mental health without ongoing clinically significant abnormalities in medical history.
* Clinically proven diagnosis of primary open-angle glaucoma (POAG) in the previous 12 months.
* Subjects with IOP not adequately controlled with the standard medication.
* Pseudophakia.
Exclusion Criteria:
* Concomitant treatment with timolol (systemic), corticosteroids, cytochrome P450 2D6 inhibitors, or α2-agonists.
* Subjects with a history of hypersensitivity or contraindications to β-blockers.
* Significant risks caused by washout of ocular hypotensive medications.
* History of any glaucoma not specified as POAG.
* History of elevated IOP due to corticosteroid use.
* History of ocular trauma.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number and proportion of participants experiencing one or more serious adverse events (SAEs)
Timeframe: From screening visit (up to Day -41) to end of study (Week 108)
2
Number and proportion of participants experiencing one or more treatment-emergent adverse events (TEAEs) overall and by dose group
Timeframe: From screening visit (up to Day -41) to end of study (Week 108)