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

NCT ID: NCT06321562

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-06-26

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.

Conditions

Primary Open-angle Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

TimoD implant

Intervention Type: DRUG

Consists of 1 TimoD implant administration in the study eye

Injector system

Intervention Type: DEVICE

This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.

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

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.

Group Type: EXPERIMENTAL

TimoD implant

Intervention Type: DRUG

Consists of 1 TimoD implant administration in the study eye

Injector system

Intervention Type: DEVICE

This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.

Group3: TimoD implant-Dose 3 (high dose)

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.

Group Type: EXPERIMENTAL

TimoD implant

Intervention Type: DRUG

Consists of 1 TimoD implant administration in the study eye

Injector system

Intervention Type: DEVICE

This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.

Interventions

TimoD implant

Consists of 1 TimoD implant administration in the study eye

Intervention Type: DRUG

Injector system

This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.

Intervention Type: DEVICE

Other Intervention Names

Intraocular implant releasing timolol; Investigational drug; ACCUJECT™ 2.2.-BL; Investigational device

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EyeD Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Breyer, Kaymak & Klabe Augenchirurgie

Düsseldorf, , Germany

Universitäts-Augenklinik Heidelberg

Heidelberg, , Germany

Universitätsaugenklinik Magdeburg

Magdeburg, , Germany

Augenklinik Sulzbach

Sulzbach, , Germany

Universitäts-Augenklinik Tübingen

Tübingen, , Germany

Countries

Germany

Other Identifiers

2024-511254-51-00

Identifier Type: CTIS

Identifier Source: secondary_id

CIV-21-12-038426

Identifier Type: OTHER

Identifier Source: secondary_id

EyeD-010-003

Identifier Type: -

Identifier Source: org_study_id