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

Wet Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685369
• Other study ID #: CHUB-Caspers
• Status: Completed
• Start date: November 10, 2020
• Est. completion date: July 28, 2021

Study information

• Verified date: March 2022
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Other:
• Medical Data extraction
Medical Data extraction

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monoyer chart result	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.	Baseline
Primary	Monoyer chart result	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.	4 months after baseline
Secondary	Central macular thickness	Central macular thickness measured by optical coherence tomography at baseline examination	Baseline
Secondary	Central macular thickness	Central macular thickness measured by optical coherence tomography at final examination	4 months after baseline
Secondary	Pigment epithelial detachment	Morphological analysis of the retinal pigment epithelium on optical coherence tomography (OCT), to assess presence or absence of detachment at baseline visit.	Baseline
Secondary	Sub-retinal fluid	Morphological analysis of retinal layers on optical coherence tomography (OCT), to assess presence or absence of sub-retinal fluid at baseline visit.	Baseline
Secondary	Choroidal neovascularization subtype	Morphological analysis of fluorescein angiography, to assess the type of choroidal neovascularization at baseline visit.	Baseline