Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma

EyeD Pharma

Status and phase: Enrolling; Phase 1

Conditions: Primary Open-angle Glaucoma

Treatments: Drug: TimoD implant; Device: Injector system

Study type: Interventional

Funder types: Industry

Identifiers

NCT06321562

2024-511254-51-00 (EU Trial (CTIS) Number)

CIV-21-12-038426 (Other Identifier)

EyeD-010-003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Group 1: TimoD implant-Dose 1 (low dose)

Experimental group

Description:

Participants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.

Treatment:

Device: Injector system

Drug: TimoD implant

Group 2: TimoD implant-Dose 2 (intermediate dose)

Experimental group

Description:

Participants in Group 2 will receive an intermediate dose of TimoD implant in the study eye on Day 1 if all participants in Group 1 have completed a 4-week treatment period with the lowest dose of TimoD implant, providing there are no safety issues in Group 1.

Treatment:

Device: Injector system

Drug: TimoD implant

Group3: TimoD implant-Dose 3 (high dose)

Experimental group

Description:

Participants in Group 3 will receive a high dose of TimoD implant in the study eye on Day 1 if all participants in Group 2 have completed a 4-week treatment period with the intermediate dose, providing there are no safety issues in Group 2.

Treatment:

Device: Injector system

Drug: TimoD implant