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NCT Number: 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

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Data extraction from medical files

Other

Data extraction from medical files

Primary outcomes

  1. Injections number (first 24 months of treatment)

    Time frame: first 24 months of treatment

    Number of injections during the first 24 months of treatment

  2. Injections interval

    Time frame: during the 2nd year of treatment

    Last injection interval during the 2nd year of treatment, in weeks

Secondary outcomes

  1. Injection number (up to 4 years of treatment)

    Time frame: up to 4 years of treatment

    Number of injections during the 1st, 2nd, 3rd and 4th year of treatment

  2. Injections interval (up to 4 years of treatment)

    Time frame: up to 4 years of treatment

    Last injection interval during the 1st, 2nd, 3rd and 4th year of treatment (if applicable), in weeks

  3. Most stable injection interval

    Time frame: up to 4 years of treatment

    Most stable injection interval during the 2nd, 3rd and 4th year of treatment (if applicable), in weeks

  4. Overall extension interval

    Time frame: up to 4 years of treatment

    Expected overall extension interval: by 1 week, 2 weeks, 3 weeks or 4 weeks

  5. Covid 19 impact

    Time frame: up to 4 years of treatment

    Covid19 impact on the injection interval (visits cancelled due to lock-down, shortening/increase of the injection interval due to hospital internal emergency procedures)

  6. Number of follow-up visits

    Time frame: up to 4 years of treatment

    Number of follow-up visits during each year of treatment up to 4 years

  7. Visual acuity

    Time frame: up to 4 years of treatment

    Visual acuity at baseline, after 90 days and at the end of each year of treatment up to 4 years

  8. Age

    Time frame: Baseline

    Age of the patient at baseline

  9. Eye lesion type

    Time frame: Baseline

    Eye lesion type

  10. Fluid

    Time frame: up to 4 years of treatment

    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

  11. Date of first symptoms

    Time frame: Baseline

    Date of first symptoms of neovascular AMD

  12. Date of first injection

    Time frame: Baseline

    Date of first ranibizumab injection

  13. Retinal thickness

    Time frame: up to 4 years of treatment

    Retinal thickness at baseline, after 90 days and at the end of each year of treatment up to 4 years

  14. Treatment regimen

    Time frame: first 12 months of treatment

    Has there been a change in treatment regimen after the first 12 months of treatment?

  15. Number of patients stopping treatment (12-24 months)

    Time frame: between 12 and 24 months of treatment

    Number of patients stopping treatment between 12 and 24 months of treatment

  16. Reason for stopping treatment (12-24 months)

    Time frame: between 12 and 24 months of treatment

    Reason for stopping treatment between 12 and 24 months of treatment

  17. Number of patients stopping treatment (24-36 months)

    Time frame: between 24 and 36 months of treatment

    Number of patients stopping treatment between 24 and 36 months of treatment

  18. Reason for stopping treatment (24-36 months)

    Time frame: between 24 and 36 months of treatment

    Reason for stopping treatment between 24 and 36 months of treatment

  19. Number of patients stopping treatment (36-48 months)

    Time frame: between 36 and 48 months of treatment

    Number of patients stopping treatment between 36 and 48 months of treatment

  20. Reason for stopping treatment (36-48 months)

    Time frame: between 36 and 48 months of treatment

    Reason for stopping treatment between 36 and 48 months of treatment

  21. Number of patients stopping treatment (first 12 months)

    Time frame: first 12 months of treatment

    Number of patients who stopped treatment in the first 12 months

  22. Reason for stopping treatment (first 12 months)

    Time frame: first 12 months of treatment

    Reason for stopping treatment in the first 12 months

Sponsors and collaborators

Lead sponsor

Laurence Postelmans

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 18, 2021
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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