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Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers

Completed
Conditions
Wet Age-related Macular Degeneration
Interventions
Other: Medical Data extraction
Registration Number
NCT04685369
Lead Sponsor
Brugmann University Hospital
Brief Summary

" Wet Age-related Macular Degeneration (wet AMD)" is characterized by the appearance of new choroidal vessels. Several clinical studies have shown the effectiveness of intra-vitreous injections of anti-VEGF (bevacizumab, ranibizumab and aflibercept) against these choroidal neovessels. However, some eyes appear to respond less well or be resistant to anti-VEGF injections, which affects visual acuity. To improve the clinical management of patients with wet AMD, it is important to be able to determine which factors determine the response to anti-VEGF treatment.

Non-modifiable factors such as visual acuity or the patient's age at the time of the first injections, the type and size of choroidal neovascularization, as well as certain genetic polymorphisms are known. Two studies, one carried out in Korean patients, the other in different centers in Singapore, New Zealand, Australia and Switzerland showed that active smoking was associated with a poorer response to intra-vitreous injections of ranibizumab, since smoking is also an already well-known modifiable risk factor for the onset of AMD. Another study in the Netherlands shows a poorer visual prognosis after five years of injection treatment in patients who smoke.

This study aims to study the effect of active smoking on the visual prognosis of patients with exudative AMD and treated with anti-VEGF injections in a Belgian cohort.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
148
Inclusion Criteria
  • CHU Brugmann Hospital patients
  • Patients who received three intra-vitreous injections of ranibizumab, aflibercept or bevacizumab 4 weeks apart as the first intra-vitreous treatment between January 2016 and December 2020.
  • Visual acuity measured before the start of the injections (maximum 1 month) and after the series of three injections (4 to 8 weeks after the last injection)
  • Patients whose smoking status is known and for whom the following history appears: hypertension, diabetes, taking anti-coagulants or anti-aggregants.
Exclusion Criteria
  • Patients who have already received another intravitreal treatment in the past.
  • Patients who have been treated with dynamic phototherapy before or at the same time as the injections.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Active smokers with wet AMDMedical Data extraction-
Primary Outcome Measures
NameTimeMethod
Monoyer chart result4 months after baseline

Best corrected visual acuity using a monoyer chart - data collected on one eye only. Monoyer charts are planks with letters displayed: the letters in each row are the same size and the size increases as you go down.

Secondary Outcome Measures
NameTimeMethod
Central macular thickness4 months after baseline

Central macular thickness measured by optical coherence tomography at final examination

Choroidal neovascularization subtypeBaseline

Morphological analysis of fluorescein angiography, to assess the type of choroidal neovascularization at baseline visit.

Sub-retinal fluidBaseline

Morphological analysis of retinal layers on optical coherence tomography (OCT), to assess presence or absence of sub-retinal fluid at baseline visit.

Pigment epithelial detachmentBaseline

Morphological analysis of the retinal pigment epithelium on optical coherence tomography (OCT), to assess presence or absence of detachment at baseline visit.

Trial Locations

Locations (1)

CHU Brugmann

🇧🇪

Brussels, Belgium

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