NCT04287348

Intravitreal Brolucizumab in Neovascular Age-related Macular Degeneration With Limited Response to Aflibercept

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Vista Klinik · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this investigator initiated study is to identify the effects of intravitreal brolucizumab on recurrence-free treatment intervals and morphological features in choroidal neovascularizations (CNV) due to age-related macular degeneration (AMD) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6, 8 or 10 weeks intervals in a treat and extend regimen using aflibercept.

Detailed description

Outcome Measures: The primary outcome is the mean maximum treatment interval with intravitreal brolucizumab at month 6 and 12. The secondary outcomes are: * Best corrected visual acuity (BCVA) in letters and BCVA change (letters) from baseline (=switch to brolucizumab) to month 6 and 12. * Number of brolucizumab intravitreal treatments applied during the 12 months study period. * Central retinal thickness (CRT, in µm) as measured in the central ETDRS subfield Spectral-Domain Optical coherence tomography (SD-OCT) at baseline, month 6 and 12. * Presence of qualitative SD-OCT features like intraretinal fluid, subretinal fluid, pigment epithelial detachment and hyperreflective foci at baseline, month 6 and 12. * Total CNV area and vessel density as measured by OCTangiography (OCTA) at baseline, month 6 and 12. * Total area of leakage from CNV and the total lesion area as evaluated by Fluorescein angiography (FA) at baseline and month 12. * VFQ-25 total and subscores as evaluated by quality of life questionnaire VFQ-25 at baseline and month 6 and 12. * Rates of adverse events and serious adverse events at 6 and 12 months.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Brolucizumab 6 mg solution for intravitreal injection	All consenting, enrolled patients (irrespectively of maximum recurrence-free interval under aflibercept pretreatment) will receive an intravitreal injection of brolucizumab 6 mg at baseline (week 0), at week 4 and each of the following treat and extend visits. At each visit all patients will undergo an OCT assessment. For all patients extension of treatment intervals is only possible 2-week-stepwise, e.g. 4, 6, 8 weeks etc.

Timeline

• Start date: 2020-07-20
• Primary completion: 2021-11-22
• Completion: 2021-11-22
• First posted: 2020-02-27
• Last updated: 2021-12-29

Locations

1 site across 1 country: Switzerland