Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06321562
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-03-13
Brief Title:
Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma
Sponsor:
EyeD Pharma
Organization:
EyeD Pharma
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-002354-24 | EUDRACT_NUMBER | None | None |
| CIV-21-12-038426 | OTHER | EUDAMED | None |