Study of brolucizumab in adult patients with suboptimal anatomically controlled neovascular age-related macular degeneratio

Phase 1

Active, not recruiting

• 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: EUCTR2019-004145-33-FR
• Lead Sponsor: ovartis Pharma S.A.S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-18
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• Patients must provide written informed consent before any study-related procedures are performed.
• Patients must be 50 years of age or older at Screening/Baseline.

Study eye:
• Active CNV lesions secondary to nAMD diagnosed < 18 months prior to Screening/Baseline that affect the central subfield, including retinal angiomatous proliferation (RAP) with a CNV component, confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and sequelae of CNV, e.g. pigment epithelial detachment (PED), subretinal hemorrhage or sub-retinal pigmented epithelium (sub RPE) hemorrhage, blocked fluorescence, or macular edema.
• Previous treatment with only one licensed anti-VEGF drug (i.e. Lucentis®, Eylea®) with residual fluid (intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield under, as seen by OCT), despite a = Q4 and = Q8 treatment (treatment interval of 26 to 62 days inclusive) with licensed anti-VEGF. Patients must have received at least 3 injections of this anti-VEGF drug in the 6 months prior to Screening/Baseline.
• Best-corrected visual acuity (BCVA) score must be = 83 and = 38 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts at Screening/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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 277

Exclusion Criteria

• Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Screening/Baseline.
• Presence of amblyopia, amaurosis, or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Screening/Baseline (except when due to conditions whose surgery may improve visual acuity, e.g. cataract).

Study eye
• Poor quality of OCT images at Screening/Baseline.
• Atrophy or fibrosis involving the center of the fovea in the study eye, as assessed by CFP and fundus autofluorescence (FAF).
• The total area of fibrosis or subretinal blood affecting the foveal center point comprising = 50% of the lesion area in the study eye.
• Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the Investigator, could require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product.
• Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg on medication or according to Investigator’s judgment.
• Previous laser treatment for nAMD including photodynamic therapy (PDT) laser at any time prior to Screening/Baseline.

Systemic conditions or treatments
• Stroke or myocardial infarction in the 6-month period prior to Screening/Baseline.
• Systemic anti-VEGF therapy at any time.

Other
• Women of childbearing potential, defined as all women less than 1 year postmenopausal or less than 6 weeks since sterilization.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of brolucizumab 6 mg on disease control ;Secondary Objective: • To evaluate the long term effects of brolucizumab 6 mg on disease control<br>• To evaluate the effect of brolucizumab 6 mg on anatomical parameters<br>• To evaluate the durability of brolucizumab 6 mg<br>• To evaluate functional outcomes<br>• To assess the safety and tolerability of brolucizumab 6 mg;Primary end point(s): Proportion of patients with no disease activity at Week 16;Timepoint(s) of evaluation of this end point: at Week 16

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Proportion of patients with no disease activity at Week 48<br>• Change from Baseline in CFST as assessed by OCT over time up to Week 48 <br>• Absence of IRF, SRF, and sub-RPE fluid as assessed by OCT over time up to Week 48<br>• Proportion of patients with a dry retina (neither IRF nor SRF) up to Week 48 <br>• Distribution of the last interval with no disease activity up to Week 48 <br>• Distribution of the maximal intervals with no disease activity up to Week 48 <br>• Average change in BCVA from Baseline up to Week 48<br>• Incidence of AEs (serious and non-serious) up to Week 48;Timepoint(s) of evaluation of this end point: • at Week 48<br>• from Baseline over time up to Week 48 <br>• over time up to Week 48<br>• up to Week 48 <br>• up to Week 48 <br>• up to Week 48 <br>• from Baseline up to Week 48<br>• up to Week 48