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Completed

NCT Number: NCT04685369

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

" 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.

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Key information

Conditions

Wet Age-related Macular Degeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Medical Data extraction

Other

Medical Data extraction

Primary outcomes

  1. Monoyer chart result

    Time frame: 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.

  2. Monoyer chart result

    Time frame: 4 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 outcomes

  1. Central macular thickness

    Time frame: Baseline

    Central macular thickness measured by optical coherence tomography at baseline examination

  2. Central macular thickness

    Time frame: 4 months after baseline

    Central macular thickness measured by optical coherence tomography at final examination

  3. Pigment epithelial detachment

    Time frame: Baseline

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

  4. Sub-retinal fluid

    Time frame: Baseline

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

  5. Choroidal neovascularization subtype

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Brugmann University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 28, 2020
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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