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

Phase 1

Recruiting

• Conditions: Primary Open-angle Glaucoma
• Interventions: Drug: TimoD implant; Device: Injector system

• Registration Number: NCT06321562
• Lead Sponsor: EyeD Pharma

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.

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Group 2: TimoD implant-Dose 2 (intermediate dose)	TimoD implant	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 2: TimoD implant-Dose 2 (intermediate dose)	Injector system	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.
Group3: TimoD implant-Dose 3 (high dose)	TimoD implant	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 1: TimoD implant-Dose 1 (low dose)	TimoD implant	Participants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
Group 1: TimoD implant-Dose 1 (low dose)	Injector system	Participants in the Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.
Group3: TimoD implant-Dose 3 (high dose)	Injector system	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.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (5)

Breyer, Kaymak & Klabe Augenchirurgie; 🇩🇪 Düsseldorf, Germany

Universitäts-Augenklinik Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsaugenklinik Magdeburg; 🇩🇪 Magdeburg, Germany

Augenklinik Sulzbach; 🇩🇪 Sulzbach, Germany

Universitäts-Augenklinik Tübingen; 🇩🇪 Tübingen, Germany