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

NCT04685369 | Completed

• 1 other identifier: CHUB-Caspers
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Wet Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Central macular thickness

  Baseline

• Central macular thickness

  4 months after baseline

• Pigment epithelial detachment

  Baseline

• Sub-retinal fluid

  Baseline

• Choroidal neovascularization subtype

  Baseline

Study Arms (1)

Active smokers with wet AMD

Other: Medical Data extraction

Interventions

Medical Data extraction OTHER

Medical Data extraction

Active smokers with wet AMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Study Officials

• Sophie Caspers

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ophtalmology department

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: November 10, 2020
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)