Clinical trial NCT06321562: Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma
Official title: A First-In-Human, Open-Label, Dose Escalating, Non-Randomized Study to Assess the Safety and Tolerability of a New Timolol Sustained Release Intraocular Implant (TimoD) in Subjects With Primary Open Angle Glaucoma With Pseudophakia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Primary Open-angle Glaucoma
Keywords: Glaucoma
POAG
Lead sponsor: EyeD Pharma
Sponsor class: INDUSTRY
First posted: 2024-03-20
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Breyer, Kaymak & Klabe Augenchirurgie
city: Heidelberg
country: Germany
facility: Universitäts-Augenklinik Heidelberg
city: Magdeburg
country: Germany
facility: Universitätsaugenklinik Magdeburg
city: Sulzbach
country: Germany
facility: Augenklinik Sulzbach
city: Tübingen
country: Germany
facility: Universitäts-Augenklinik Tübingen
Study officials:
References: