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 range40 Years

SexALL

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.

What they're measuring

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)

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)

Trial details

NCT IDNCT06321562

SponsorEyeD Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-26

View on ClinicalTrials.gov More Primary Open-angle Glaucoma trials

Plain-language summary

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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)

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)