Analysis of naïve Patients With Age-related Macular Degeneration Neovascular Type and Treated With Ranibizumab (Lucentis®) in Treat-and-extend at the CHU Brugmann.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- Injections number (first 24 months of treatment) [first 24 months of treatment]
Number of injections during the first 24 months of treatment
- Injections interval [during the 2nd year of treatment]
Last injection interval during the 2nd year of treatment, in weeks
Secondary Outcome Measures
- Injection number (up to 4 years of treatment) [up to 4 years of treatment]
Number of injections during the 1st, 2nd, 3rd and 4th year of treatment
- Injections interval (up to 4 years of treatment) [up to 4 years of treatment]
Last injection interval during the 1st, 2nd, 3rd and 4th year of treatment (if applicable), in weeks
- Most stable injection interval [up to 4 years of treatment]
Most stable injection interval during the 2nd, 3rd and 4th year of treatment (if applicable), in weeks
- Overall extension interval [up to 4 years of treatment]
Expected overall extension interval: by 1 week, 2 weeks, 3 weeks or 4 weeks
- Covid 19 impact [up to 4 years of treatment]
Impact of Covid-19 on the injection interval
- Number of follow-up visits [up to 4 years of treatment]
Number of follow-up visits during each year of treatment
- Visual acuity [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
- Age [Baseline]
Age of the patient at baseline
- Eye lesion type [Baseline]
Eye lesion type
- Fluid [Baseline]
Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium
- Fluid [90 days after baseline]
Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium
- Fluid [once a year up to 4 years of treatment]
Presence or absence of intra-retinal fluid, subretinal fluid, detachment of the pigment epithelium
- Date of first symptoms [Baseline]
Date of first symptoms of neovascular AMD
- Date of first injection [Baseline]
Date of first ranibizumab injection
- Retinal thickness [up to 4 years of treatment]
Retinal thickness at baseline, after 90 days and at the end of each year of treatment
- Treatment regimen [first 12 months of treatment]]
Has there been a change in treatment regimen after the first 12 months of treatment?
- Number of patients stopping treatment (12-24 months) [between 12 and 24 months of treatment]
Number of patients stopping treatment between 12 and 24 months of treatment
- Reason for stopping treatment (12-24 months) [between 12 and 24 months of treatment]
Reason for stopping treatment between 12 and 24 months of treatment
- Number of patients stopping treatment (24-36 months) [between 24 and 36 months of treatment]
Number of patients stopping treatment between 24 and 36 months of treatment
- Reason for stopping treatment (24-36 months) [between 24 and 36 months of treatment]
Reason for stopping treatment between 24 and 36 months of treatment
- Number of patients stopping treatment (36-48 months) [between 36 and 48 months of treatment]
Number of patients stopping treatment between 36 and 48 months of treatment
- Reason for stopping treatment (36-48 months) [between 36 and 48 months of treatment]
Reason for stopping treatment between 36 and 48 months of treatment
- Number of patients stopping treatment (first 12 months) [First 12 months of treatment]
Number of patients who stopped treatment in the first 12 months
- Reason for stopping treatment (first 12 months) [First 12 months of treatment]
Reason for stopping treatment in the first 12 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients> 50 years old diagnosed with neovascular age related macular degeneration,
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Patients who have never received anti-VEGF treatment,
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Patients who started intra-vitreous injections of ranibizumab between 01 January 2014 and November 30, 2019,
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Treatment by "treat-and-extend" directly after the loading dose of ranibizumab,
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Availability of the medical file reporting treatment with ranibizumab.
Exclusion Criteria:
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Participation in an interventional clinical study during treatment with ranibizumab,
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Patients suffering from ocular pathologies and having required surgery during the first 24 months of treatment with ranibizumab (for example advanced glaucoma or cataract).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Brugmann | Brussels | Belgium | 1020 |
Sponsors and Collaborators
- Brugmann University Hospital
Investigators
- Study Director: Laurence Postelmans, CHU Brugmann
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CHUB- KIERKOWICZ