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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Other: Data extraction from medical files


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Data extraction from medical files|Data extraction from medical files|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injections number (first 24 months of treatment) | Number of injections during the first 24 months of treatment | first 24 months of treatment | 
| Injections interval | Last injection interval during the 2nd year of treatment, in weeks | during the 2nd year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injection number (up to 4 years of treatment) | Number of injections during the 1st, 2nd, 3rd and 4th year of treatment | up to 4 years of treatment | 
| Injections interval (up to 4 years of treatment) | Last injection interval during the 1st, 2nd, 3rd and 4th year of treatment (if applicable), in weeks | up to 4 years of treatment | 
| Most stable injection interval | Most stable injection interval during the 2nd, 3rd and 4th year of treatment (if applicable), in weeks | up to 4 years of treatment | 
| Overall extension interval | Expected overall extension interval: by 1 week, 2 weeks, 3 weeks or 4 weeks | up to 4 years of treatment | 
| Covid 19 impact | Covid19 impact on the injection interval (visits cancelled due to lock-down, shortening/increase of the injection interval due to hospital internal emergency procedures) | up to 4 years of treatment | 
| Number of follow-up visits | Number of follow-up visits during each year of treatment up to 4 years | up to 4 years of treatment | 
| Visual acuity | Visual acuity at baseline, after 90 days and at the end of each year of treatment up to 4 years | up to 4 years of treatment | 
| Age | Age of the patient at baseline | Baseline | 
| Eye lesion type | Eye lesion type | Baseline | 
| Fluid | Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium at baseline, after 90 days and at the end of each year of treatment up to 4 years | up to 4 years of treatment | 
| Date of first symptoms | Date of first symptoms of neovascular AMD | Baseline | 
| Date of first injection | Date of first ranibizumab injection | Baseline | 
| Retinal thickness | Retinal thickness at baseline, after 90 days and at the end of each year of treatment up to 4 years | up to 4 years of treatment | 
| Treatment regimen | Has there been a change in treatment regimen after the first 12 months of treatment? | first 12 months of treatment | 
| Number of patients stopping treatment (12-24 months) | Number of patients stopping treatment between 12 and 24 months of treatment | between 12 and 24 months of treatment | 
| Reason for stopping treatment (12-24 months) | Reason for stopping treatment between 12 and 24 months of treatment | between 12 and 24 months of treatment | 
| Number of patients stopping treatment (24-36 months) | Number of patients stopping treatment between 24 and 36 months of treatment | between 24 and 36 months of treatment | 
| Reason for stopping treatment (24-36 months) | Reason for stopping treatment between 24 and 36 months of treatment | between 24 and 36 months of treatment | 
| Number of patients stopping treatment (36-48 months) | Number of patients stopping treatment between 36 and 48 months of treatment | between 36 and 48 months of treatment | 
| Reason for stopping treatment (36-48 months) | Reason for stopping treatment between 36 and 48 months of treatment | between 36 and 48 months of treatment | 
| Number of patients stopping treatment (first 12 months) | Number of patients who stopped treatment in the first 12 months | first 12 months of treatment | 
| Reason for stopping treatment (first 12 months) | Reason for stopping treatment in the first 12 months | first 12 months of treatment |