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

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.

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Other: Data extraction from medical files

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Naive patients with age-related macular degeneration, neovascular type, treated with ranibizumab (Lucentis®) in "treat-and-extend" at the CHU Brugmann Hospital.

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injection number (up to 4 years of treatment)	Number of injections during the 1st, 2nd, 3rd and 4th year of treatment	up to 4 years of treatment
Injections interval (up to 4 years of treatment)	Last injection interval during the 1st, 2nd, 3rd and 4th year of treatment (if applicable), in weeks	up to 4 years of treatment
Most stable injection interval	Most stable injection interval during the 2nd, 3rd and 4th year of treatment (if applicable), in weeks	up to 4 years of treatment
Overall extension interval	Expected overall extension interval: by 1 week, 2 weeks, 3 weeks or 4 weeks	up to 4 years of treatment
Age	Age of the patient at baseline	Baseline
Eye lesion type	Eye lesion type	Baseline
Date of first symptoms	Date of first symptoms of neovascular AMD	Baseline
Date of first injection	Date of first ranibizumab injection	Baseline
Number of patients stopping treatment (12-24 months)	Number of patients stopping treatment between 12 and 24 months of treatment	between 12 and 24 months of treatment
Reason for stopping treatment (12-24 months)	Reason for stopping treatment between 12 and 24 months of treatment	between 12 and 24 months of treatment
Number of patients stopping treatment (24-36 months)	Number of patients stopping treatment between 24 and 36 months of treatment	between 24 and 36 months of treatment
Reason for stopping treatment (24-36 months)	Reason for stopping treatment between 24 and 36 months of treatment	between 24 and 36 months of treatment
Number of patients stopping treatment (36-48 months)	Number of patients stopping treatment between 36 and 48 months of treatment	between 36 and 48 months of treatment
Reason for stopping treatment (36-48 months)	Reason for stopping treatment between 36 and 48 months of treatment	between 36 and 48 months of treatment
Covid 19 impact	Impact of Covid-19 on the injection interval	up to 4 years of treatment
Number of follow-up visits	Number of follow-up visits during each year of treatment	up to 4 years of treatment
Visual acuity	Visual acuity at baseline, after 90 days and at the end of each year of treatment in the study	up to 4 years of treatment
Fluid	Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium	Baseline
Fluid	Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium	90 days after baseline
Fluid	Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium	once a year up to 4 years of treatment
Retinal thickness	Retinal thickness at baseline, after 90 days and at the end of each year of treatment	up to 4 years of treatment
Treatment regimen	Has there been a change in treatment regimen after the first 12 months of treatment?	first 12 months of treatment]
Number of patients stopping treatment (first 12 months)	Number of patients who stopped treatment in the first 12 months	First 12 months of treatment
Reason for stopping treatment (first 12 months)	Reason for stopping treatment in the first 12 months	First 12 months of treatment

Collaborators and Investigators

• Sponsor: Brugmann University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2021
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: May 10, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: CHUB- KIERKOWICZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No