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

Last updated: January 28, 2025
Sponsor: EyeD Pharma
Overall Status: Active - Recruiting

Phase

1

Condition

Glaucoma

Treatment

Injector system

TimoD implant

Clinical Study ID

NCT06321562
EyeD-010-003
2020-002354-24
2024-511254-51-00
CIV-21-12-038426
  • Ages > 40
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Capable of giving signed informed consent.

  • In good general and mental health without ongoing clinically significantabnormalities in medical history.

  • Clinically proven diagnosis of primary open-angle glaucoma (POAG) in the previous 12months.

  • Subjects with IOP not adequately controlled with the standard medication.

  • Pseudophakia.

Exclusion

Exclusion Criteria:

  • Concomitant treatment with timolol (systemic), corticosteroids, cytochrome P450 2D6inhibitors, 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

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: Injector system
Phase: 1
Study Start date:
March 01, 2023
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • CHU - Service d'Ophtalmologie

    Liège, 4000
    Belgium

    Site Not Available

  • Breyer, Kaymak & Klabe Augenchirurgie

    Düsseldorf, 40212
    Germany

    Active - Recruiting

  • Universitäts-Augenklinik Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Universitätsaugenklinik Magdeburg

    Magdeburg, 39120
    Germany

    Active - Recruiting

  • Augenklinik Sulzbach

    Sulzbach, 66280
    Germany

    Active - Recruiting

  • Universitäts-Augenklinik Tübingen

    Tübingen, 72076
    Germany

    Active - Recruiting

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