Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-01 @ 11:10 PM
Study NCT ID:
NCT04891835
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2021-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of naïve Patients With Age-related Macular Degeneration of the Neovascular Type and Treated With Aflibercept (Eylea®) in "Treat-and-extend" at CHU Brugmann
Sponsor:
Laurence Postelmans
Organization:
Study Overview
Official Title:
Retrospective Analysis of naïve Patients With Age-related Macular Degeneration of the Neovascular Type and Treated With Aflibercept (Eylea®) in "Treat-and-extend" at CHU Brugmann
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50. Neovascular AMD, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels. One of the major molecular mediators is vascular endothelial growth factor (VEGF).
Intra-vitreous (IVI) injection of an anti-VEGF can slow the progression of neovascular AMD and stabilize vision in the majority of cases. Aflibercept (Eylea®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.
At the start of its use, aflibercept was first injected monthly and then according to the PRN "reactive" protocol (Pro Renata). Over time, a new treatment strategy has emerged: the "treat-and-extend" (T\&E). This is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. This begins with the loading dose, i.e. 3 injections given 4 weeks apart. Thereafter, the interval is lengthened in increments of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IVI.
The efficacy and safety of aflibercept, when used in a proactive T\&E regimen, was demonstrated in the randomized controlled trial, ALTAIR. However, data on T\&E used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period.
The aim of this retrospective study carried out at the CHU Brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.
Intra-vitreous (IVI) injection of an anti-VEGF can slow the progression of neovascular AMD and stabilize vision in the majority of cases. Aflibercept (Eylea®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.
At the start of its use, aflibercept was first injected monthly and then according to the PRN "reactive" protocol (Pro Renata). Over time, a new treatment strategy has emerged: the "treat-and-extend" (T\&E). This is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. This begins with the loading dose, i.e. 3 injections given 4 weeks apart. Thereafter, the interval is lengthened in increments of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IVI.
The efficacy and safety of aflibercept, when used in a proactive T\&E regimen, was demonstrated in the randomized controlled trial, ALTAIR. However, data on T\&E used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period.
The aim of this retrospective study carried out at the CHU Brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: