Clinical trial NCT04685369: Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers
Official title: Effectiveness of Anti-VEGF Treatments in Wet AMD in Active Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wet Age-related Macular Degeneration
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the CHU Brugmann Hospital with Wet AMD having received intra-vitreous injections of anti-VEGF, with a known smoking status.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Monoyer chart result
timeFrame: Baseline
measure: Monoyer chart result
timeFrame: 4 months after baseline
Secondary outcomes:
measure: Central macular thickness
timeFrame: Baseline
measure: Central macular thickness
timeFrame: 4 months after baseline
measure: Pigment epithelial detachment
timeFrame: Baseline
measure: Sub-retinal fluid
timeFrame: Baseline
measure: Choroidal neovascularization subtype
timeFrame: Baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Sophie Caspers
role: PRINCIPAL_INVESTIGATOR
References: