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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Age-related Macular Degeneration
- Sponsor
- Laurence Postelmans
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Injections number (first 24 months of treatment)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Laurence Postelmans
Head of Opthalmology clinic
Brugmann University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients\> 50 years old diagnosed with neovascular age related macular degeneration,
- •Patients who have never received anti-VEGF treatment,
- •Patients who started intra-vitreous injections of aflibercept between 01 January 2014 and November 30, 2019,
- •Treatment by "treat-and-extend" directly after the loading dose of aflibercept,
- •Availability of the medical file reporting treatment with aflibercept.
Exclusion Criteria
- •Participation in an interventional clinical study during treatment with aflibercept,
- •Patients with ocular pathologies who required surgery during the first 24 months of treatment with aflibercept (eg advanced glaucoma or cataracts).
Outcomes
Primary Outcomes
Injections number (first 24 months of treatment)
Time Frame: first 24 months of treatment
Number of injections during the first 24 months of treatment
Injections interval
Time Frame: during the 2nd year of treatment
Last injection interval during the 2nd year of treatment, in weeks
Secondary Outcomes
- Number of patients stopping treatment (12-24 months)(between 12 and 24 months of treatment)
- Visual acuity(up to 4 years of treatment)
- Age(Baseline)
- Eye lesion type(Baseline)
- Retinal thickness(up to 4 years of treatment)
- Number of patients stopping treatment (24-36 months)(between 24 and 36 months of treatment)
- Reason for stopping treatment (24-36 months)(between 24 and 36 months of treatment)
- Injections interval (up to 4 years of treatment)(up to 4 years of treatment)
- Most stable injection interval(up to 4 years of treatment)
- Covid 19 impact(up to 4 years of treatment)
- Number of patients stopping treatment (36-48 months)(between 36 and 48 months of treatment)
- Reason for stopping treatment (36-48 months)(between 36 and 48 months of treatment)
- Injection number (up to 4 years of treatment)(up to 4 years of treatment)
- Fluid(up to 4 years of treatment)
- Date of first symptoms(Baseline)
- Date of first injection(Baseline)
- Reason for stopping treatment (12-24 months)(between 12 and 24 months of treatment)
- Number of patients stopping treatment (first 12 months)(first 12 months of treatment)
- Overall extension interval(up to 4 years of treatment)
- Number of follow-up visits(up to 4 years of treatment)
- Treatment regimen(first 12 months of treatment)
- Reason for stopping treatment (first 12 months)(first 12 months of treatment)