Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)

A 64-week, Two-arm, Randomized, Double-masked, Multicenter, Phase IIIb Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen in Patients With Neovascular Agerelated Macular Degeneration (TALON)

ClinicalTrials.gov Identifier: NCT04005352

Novartis Reference Number: CRTH258A2303

Last Update: Sep 18, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

The study is a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study in patients with nAMD (neovascular age related macular degeneration) who have not previously received anti-VEGF (vascular endothelial growth factor) treatment. Patients who consent will undergo screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria.

Condition

Age-related Macular Degeneration

Macular Degeneration

Wet Macular Degeneration

Retinal Degeneration

Retinal Diseases

Eye Diseases

Phase

Phase 3

Overall status

Recruiting

Enrollment count

692 participants

Start date

Sep 25, 2019

Completion date

Oct 04, 2022

Gender

All

Age(s)

50 Years and older (Adult, Older Adult)

Interventions

Biological

Brolucizumab 6 mg

3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62.

Biological

Aflibercept 2 mg

3 x 4-week injections and one 8-week injection, followed by Treat-to- Control treatment from Week 16 up to Week 60/62

Eligibility Criteria

Inclusion Criteria:

Signed informed consent must be obtained prior to participation in the study
Male or female patients ≥ 50 years of age at screening who are treatment naive
Active choroidal neovascularization (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 (study eye)
Presence of intraretinal fluid (IRF) or subretinal fluid (SRF) that affects the central subfield, as seen by Spectral Domain Optical Coherence Tomography (SD-OCT) (study eye)
Best-corrected visual acuity (BCVA) score between 83 and 38 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)

Exclusion Criteria:

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)
Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)
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)
Stroke or myocardial infarction during the 6-month period prior to baseline
Systemic anti-VEGF therapy at any time.

Other protocol-defined inclusion/exclusion criteria may apply