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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
First received
Last updated
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
Health authority
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.

Study Design


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)
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