MedTrace Logo

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

NCT04287348 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-12-29

No results posted yet for this study

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.

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

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.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Vista Klinik

    lead OTHER

Principal Investigators

  • Katja Hatz, PD Dr. med · Vista Klinik Binningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2021-11-22
Completion
2021-11-22

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04287348 on ClinicalTrials.gov