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

NCT04891835 | Completed

• 1 other identifier: CHUB-CHRAIBI-KAADOUD
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• Injection number (up to 4 years of treatment)

  up to 4 years 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

• Overall extension interval

  up to 4 years of treatment

• Covid 19 impact

  up to 4 years of treatment

Interventions

Data extraction from medical files OTHER

Data extraction from medical files

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Laurence Postelmans: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Laurence Postelmans

  CHU Brugmann

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Opthalmology clinic

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: April 13, 2021
• Primary Completion: September 22, 2021
• Study Completion: September 22, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)