Clinical trial NCT04891835: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 36
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the CHU Brugmann Hospital, \> 50 years old, diagnosed with neovascular age related macular degeneration, who have never received anti-VEGF treatment, and who started intra-vitreous injections of aflibercept between 01 January 2014 and November 30, 2019.

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.


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).

Primary outcomes:
measure: Injections number (first 24 months of treatment)
timeFrame: first 24 months of treatment
measure: Injections interval
timeFrame: during the 2nd year of treatment
Secondary outcomes:
measure: Injection number (up to 4 years of treatment)
timeFrame: up to 4 years of treatment
measure: Injections interval (up to 4 years of treatment)
timeFrame: up to 4 years of treatment
measure: Most stable injection interval
timeFrame: up to 4 years of treatment
measure: Overall extension interval
timeFrame: up to 4 years of treatment
measure: Covid 19 impact
timeFrame: up to 4 years of treatment
measure: Number of follow-up visits
timeFrame: up to 4 years of treatment
measure: Visual acuity
timeFrame: up to 4 years of treatment
measure: Age
timeFrame: Baseline
measure: Eye lesion type
timeFrame: Baseline
measure: Fluid
timeFrame: up to 4 years of treatment
measure: Date of first symptoms
timeFrame: Baseline
measure: Date of first injection
timeFrame: Baseline
measure: Retinal thickness
timeFrame: up to 4 years of treatment
measure: Treatment regimen
timeFrame: first 12 months of treatment
measure: Number of patients stopping treatment (12-24 months)
timeFrame: between 12 and 24 months of treatment
measure: Reason for stopping treatment (12-24 months)
timeFrame: between 12 and 24 months of treatment
measure: Number of patients stopping treatment (24-36 months)
timeFrame: between 24 and 36 months of treatment
measure: Reason for stopping treatment (24-36 months)
timeFrame: between 24 and 36 months of treatment
measure: Number of patients stopping treatment (36-48 months)
timeFrame: between 36 and 48 months of treatment
measure: Reason for stopping treatment (36-48 months)
timeFrame: between 36 and 48 months of treatment
measure: Number of patients stopping treatment (first 12 months)
timeFrame: first 12 months of treatment
measure: Reason for stopping treatment (first 12 months)
timeFrame: first 12 months of treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Laurence Postelmans
role: STUDY_DIRECTOR
References: