Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539481
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Open Label Trial Studying the Safety and Effectiveness of ILUVIEN 190μg in Children and Adolescents Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Non-randomised Open-label Uncontrolled Multi-centre Phase IIIb Study Evaluating the Safety and Efficacy of Fluocinolone Acetonide 190 Micrograms Intravitreal Implant in Paediatric Subjects From 6 Years to Less Than 18 Years With Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main aim is to test how safe and effective the medicine ILUVIEN 190μg is for children and adolescents who have non-infectious uveitis that keeps coming back and affects the back of the eye
The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye Treatment success will be measured after 6 months of using the implant
The treatment will be considered successful if two things happen
1 No swelling in the back of the eye called cystoid macular oedema
2 A decrease in the cloudiness inside the eye called vitreous haze by at least two levels compared to how it was before the treatment or the vitreous haze is completely gone
Participants will
1 Receive a single treatment with ILUVIEN which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid fluocinolone acetonide in the eye for up to 36 months
2 Be followed for 36 months for checkups and tests
The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye Treatment success will be measured after 6 months of using the implant
The treatment will be considered successful if two things happen
1 No swelling in the back of the eye called cystoid macular oedema
2 A decrease in the cloudiness inside the eye called vitreous haze by at least two levels compared to how it was before the treatment or the vitreous haze is completely gone
Participants will
1 Receive a single treatment with ILUVIEN which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid fluocinolone acetonide in the eye for up to 36 months
2 Be followed for 36 months for checkups and tests
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None