Study to evaluate the safety, efficacy, and the period between treatments of brolucizumab 6 mg compared with aflibercept 2 mg in neovascular Age-Related Macular Degeneration (nAMD), also commonly referred to as wet AMD

Phase 1

• Conditions: neovascular age-related macular degeneration; MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-000716-28-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-05
• Study Completion: 2022-09-09
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 734

Inclusion Criteria

1.Signed informed consent must be obtained prior to participation in the study.
2.Male or female patients, = 50 years of age at screening.
Study Eye:
3.Active CNV secondary to AMD that affects the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography and sequellae of CNV, e.g. pigment epithelial detachment (PED), subretinal or sub-retinal pigment epithelium (sub-RPE) hemorrhage, blocked fluorescence, macular edema.
4.Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by SD-OCT.
5.BCVA score must be = 83 and = 38 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximately Snellen equivalent of 20/25 and 20/200), at both screening and baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 346
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 346

Exclusion Criteria

1.Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
2.Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
3.Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator’s judgment, at screening or baseline (study eye)
4.Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions which can lead to improved VA after surgery eg cataract)
5.Ocular treatments: previous treatment with any anti-vascular endothelial growth factor (VEGF) drugs or investigational drugs, intraocular or periocular steroids, macular laser photocoagulation, photodynamic therapy, vitreoretinal surgery, intraocular surgery (study eye)
6.Stroke or myocardial infarction during the 6-month period prior to baseline
7.Systemic anti-VEGF therapy at any time.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified