NCT07036510

Safety of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery

Early Feasibility, Open-Label, Dose-Escalating, Non-Randomized Study to Evaluate the Safety of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: EyeD Pharma · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery. The main questions it aims to answer are how safe are three different doses of 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, * if and 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. This procedure will be performed in conjunction with the cataract surgery. Three dose ranges of TimoD implant will be tested (low, intermediate, and high) in 3 groups of 6 participants.Participants will receive only one dose. The Timolol will be released slowly through the implant for up to 1 year.

Conditions

• Glaucoma
• Ocular Hypertension

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: 2025-06-12
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-06-25
• Last updated: 2025-06-25

Locations

1 site across 1 country: Panama