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

NCT ID: NCT04891835

Last Updated: 2022-03-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-13
• Study Completion Date: 2021-09-22

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.

Conditions

Age-related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Data extraction from medical files

Data extraction from medical files

Intervention Type: OTHER

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laurence Postelmans

OTHER

Sponsor Role: lead

Responsible Party

Laurence Postelmans

Head of Opthalmology clinic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Laurence Postelmans

Role: STUDY_DIRECTOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Countries

Belgium

Other Identifiers

CHUB-CHRAIBI-KAADOUD

Identifier Type: -

Identifier Source: org_study_id