Clinical trial 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.
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 34
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


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 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).

Primary outcomes:
measure: Injections number (first 24 months of treatment)
timeFrame: first 24 months of treatment
measure: Injections interval
timeFrame: during the 2nd year of treatment
Secondary outcomes:
measure: Injection number (up to 4 years of treatment)
timeFrame: up to 4 years of treatment
measure: Injections interval (up to 4 years of treatment)
timeFrame: up to 4 years of treatment
measure: Most stable injection interval
timeFrame: up to 4 years of treatment
measure: Overall extension interval
timeFrame: up to 4 years of treatment
measure: Covid 19 impact
timeFrame: up to 4 years of treatment
measure: Number of follow-up visits
timeFrame: up to 4 years of treatment
measure: Visual acuity
timeFrame: up to 4 years of treatment
measure: Age
timeFrame: Baseline
measure: Eye lesion type
timeFrame: Baseline
measure: Fluid
timeFrame: Baseline
measure: Fluid
timeFrame: 90 days after baseline
measure: Fluid
timeFrame: once a year up to 4 years of treatment
measure: Date of first symptoms
timeFrame: Baseline
measure: Date of first injection
timeFrame: Baseline
measure: Retinal thickness
timeFrame: up to 4 years of treatment
measure: Treatment regimen
timeFrame: first 12 months of treatment]
measure: Number of patients stopping treatment (12-24 months)
timeFrame: between 12 and 24 months of treatment
measure: Reason for stopping treatment (12-24 months)
timeFrame: between 12 and 24 months of treatment
measure: Number of patients stopping treatment (24-36 months)
timeFrame: between 24 and 36 months of treatment
measure: Reason for stopping treatment (24-36 months)
timeFrame: between 24 and 36 months of treatment
measure: Number of patients stopping treatment (36-48 months)
timeFrame: between 36 and 48 months of treatment
measure: Reason for stopping treatment (36-48 months)
timeFrame: between 36 and 48 months of treatment
measure: Number of patients stopping treatment (first 12 months)
timeFrame: First 12 months of treatment
measure: Reason for stopping treatment (first 12 months)
timeFrame: First 12 months of treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Laurence Postelmans
role: STUDY_DIRECTOR
References: