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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04685369
Enrollment
148
Registered
2020-12-28
Start date
2020-11-10
Completion date
2021-07-28
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-related Macular Degeneration

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.

Interventions

Medical Data extraction

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Monoyer chart resultBaselineBest 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

MeasureTime frameDescription
Central macular thicknessBaselineCentral macular thickness measured by optical coherence tomography at baseline examination
Pigment epithelial detachmentBaselineMorphological analysis of the retinal pigment epithelium on optical coherence tomography (OCT), to assess presence or absence of detachment at baseline visit.
Sub-retinal fluidBaselineMorphological analysis of retinal layers on optical coherence tomography (OCT), to assess presence or absence of sub-retinal fluid at baseline visit.
Choroidal neovascularization subtypeBaselineMorphological analysis of fluorescein angiography, to assess the type of choroidal neovascularization at baseline visit.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026