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Completed

NCT Number: NCT04988178

Analysis of naïve Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.

Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50 years old. Neovascular AMD, the most severe form and the most severe is characterized by the appearance, spread and growth of subretinal neovessels. One of the major molecular mediators is the endothelial growth factor vascular (VEGF).

Intra-vitreous (IVI) injection of an anti-VEGF may slow the progression of Neovascular AMD and stabilize vision in the majority of cases. Ranibizumab (Lucentis®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD.

At the start of its use, ranibizumab was first injected monthly and then according to the "reactive" protocol. Over time, a new strategy of treatment was born: the "treat-and-extend" (T&E). This is 'made to measure' protocol for each patient aiming to reduce the frequency of injections while guaranteeing inactivity of the disease. It starts with the loading dose, i.e. 3 injections given 4 weeks apart. Subsequently, the interval is lengthened by slices 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 IIV.

The efficacy and safety of ranibizumab, when used in a proactive regimen of T&E, has been shown in the CANTREAT randomized controlled trial. However, there is a lack of more data on T&E used in current practice, and particularly on the number of injections and treatment intervals over a minimum treatment period of 24 months.

The aim of this retrospective study carried out at the CHU Brugmann Hospital is to determine the number of injections and the intervals necessary to have encouraging results in visual acuity over a treatment period of at least two years.

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Key information

Conditions

Macular Degeneration Eye Diseases 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 ranibizumab between 01 January 2014 and November 30, 2019,
  • Treatment by "treat-and-extend" directly after the loading dose of ranibizumab,
  • Availability of the medical file reporting treatment with ranibizumab.

Exclusion criteria

  • Participation in an interventional clinical study during treatment with ranibizumab,
  • Patients suffering from ocular pathologies and having required surgery during the first 24 months of treatment with ranibizumab (for example advanced glaucoma or cataract).

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

    Impact of Covid-19 on the injection interval

  6. Number of follow-up visits

    Time frame: up to 4 years of treatment

    Number of follow-up visits during each year of treatment

  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 in the study

  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: Baseline

    Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium

  11. Fluid

    Time frame: 90 days after baseline

    Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium

  12. Fluid

    Time frame: once a year up to 4 years of treatment

    Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium

  13. Date of first symptoms

    Time frame: Baseline

    Date of first symptoms of neovascular AMD

  14. Date of first injection

    Time frame: Baseline

    Date of first ranibizumab injection

  15. 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

  16. Treatment regimen

    Time frame: first 12 months of treatment]

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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

Brugmann University Hospital

Other

Registry information

Official study title

Retrospective Analysis of Naive Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2021
Registry last updated
Mar 21, 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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