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

Primary Open-angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321562
• Other study ID #: EyeD-010-003
• Secondary ID: 2020-002354-24CI
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2023
• Est. completion date: July 2027

Study information

• Verified date: March 2024
• Source: EyeD Pharma
• Contact: EyeD Pharma
• Phone: +32 4 229 90 00
• Email: dpo[@]eyedpharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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, at least 12 months after surgery.

Exclusion Criteria:

• Concomitant treatment with timolol (systemic), corticosteroids, cytochrome P450 2D6 inhibitors, or a2-agonists.
• Subjects with a history of hypersensitivity or contraindications to ß-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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

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.

Locations

Country	Name	City	State
Belgium	CHU - Service d'Ophtalmologie	Liège
Germany	Breyer, Kaymak & Klabe Augenchirurgie	Düsseldorf
Germany	Universitäts-Augenklinik Heidelberg	Heidelberg
Germany	Universitätsaugenklinik Magdeburg	Magdeburg
Germany	Augenklinik Sulzbach	Sulzbach
Germany	Universitäts-Augenklinik Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
EyeD Pharma

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)