Primary Open-angle Glaucoma
Conditions
Keywords
Glaucoma, POAG
Brief 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.
Detailed description
Timolol will be delivered through an investigational drug called 'TimoD implant'. This implant is placed inside one eye, the study eye, with the help of an instrument (investigational device) called an injector system. Three dose ranges of TimoD implant will be tested (low, intermediate, and high) in 3 groups of 6 participants. The Timolol will be released slowly through the implant for up to 1 year (main phase). Approximately 1 year after the TimoD implant is placed into the eye and in absence of contraindications, the participants will be invited to continue the study in an extension phase. If the participants agree to enter the extension phase and the study investigator confirms it is safe for them, the TimoD implant will remain in the study eye for one additional year.
Interventions
DRUGTimoD implant
Consists of 1 TimoD implant administration in the study eye
DEVICEInjector system
This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as anintraocular implant injection system outside of its scope of intended use.
Sponsors
EyeD Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and proportion of participants experiencing one or more serious adverse events (SAEs) | 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 | From screening visit (up to Day -41) to end of study (Week 108) |
Countries
Germany
Outcome results
None listed