NCT06321562

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: EyeD Pharma · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	TimoD implant	Consists of 1 TimoD implant administration in the study eye
DEVICE	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.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-06-26
• Completion: 2025-06-26
• First posted: 2024-03-20
• Last updated: 2025-07-16

Locations

5 sites across 1 country: Germany