Effectiveness of Anti-VEGF Treatments in Wet AMD in Activ... | NCT04685369

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

NCT04685369

Sponsor

Brugmann University Hospital

Status

Completed

Last Update Posted

Mar 8, 2022Actual

Enrollment

148Actual

Phase

Not provided

Conditions

Wet Age-related Macular Degeneration

Interventions

Medical Data extraction

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2020Actual

Primary Completion Date

Jul 28, 2021Actual

Completion Date

Jul 28, 2021Actual

First Submitted Date

Dec 22, 2020

First Submission Date that Met QC Criteria

Dec 22, 2020

First Posted Date

Dec 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2022

Last Update Posted Date

Mar 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Laurence Postelmans, Head of ophtalmology department, Brugmann University HospitalPrincipal Investigator

Lead Sponsor

Brugmann University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

148Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active smokers with wet AMD			Other: Medical Data extraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Data extraction	Other	Medical Data extraction	Active smokers with wet AMD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Central macular thickness	Central macular thickness measured by optical coherence tomography at baseline examination	Baseline
Central macular thickness	Central macular thickness measured by optical coherence tomography at final examination

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients of the CHU Brugmann Hospital with Wet AMD having received intra-vitreous injections of anti-VEGF, with a known smoking status.

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Sophie Caspers	CHU Brugmann	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
CHU Brugmann		Brussels		1020	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided