Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens in Neovascular Age-related Macular Degeneration

A 52-week, Two Arm, Randomized, Open-label, Multicenter Study Assessing the Efficacy and Safety of Two Different Brolucizumab 6 mg Dosing Regimens for Patients With Suboptimal Anatomically Controlled Neovascular Age-related Macular Degeneration

ClinicalTrials.gov Identifier: NCT04679935

Novartis Reference Number: CRTH258ADE01

Last Update: May 09, 2022

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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 purpose of this study is to evaluate the efficacy and safety of two different brolucizumab 6 mg dosing regimens in patients with visual impairment due to age-related macular degeneration (AMD) who have previously received anti-VEGF (vascular endothelial growth factor) treatment.

Condition 
Age-related Macular Degeneration
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Phase 
Phase 4
Overall status 
Recruiting
Start date 
Jul 13, 2021
Completion date 
May 31, 2024
Gender 
All
Age(s)
50 Years - 99 Years (Adult, Older Adult)

Interventions

Biological
Brolucizumab
Intravitreal injection
Biological
Brolucizumab
Intravitreal injection
Biological
Brolucizumab
Intravitreal injection

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
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 (intraretinal fluid (IRF) and/or subretinal fluid (SRF) and/or sub-retinal pigment epithelium (sub-RPE) fluid that affects the central subfield, as seen by spectral domain optical coherence tomography (SD-OCT)) at screening, as confirmed by central reading center (study eye). If active CNV according to the above explained activity criteria is not detectable in screening image data (no IRF and no SRF), presence of residual and/or recurrent fluid (IRF and / or SRF) within the last 6 months before baseline visit is also considered eligible. In this case, historical images must be submitted for analysis by the central reading center.
Pretreatment with any anti-VEGF drug for a maximum of five years (60 months). Patients should have shown functional and/or anatomical treatment response to the pretreatment(s), prior to participating in this study.
The treatment initiation phase with the current anti-VEGF must have been completed for at least 6 months with continuous treatment in a ≥ q4w to ≤ q12w injection interval (±2-day window, i.e., 26 to 86 days inclusive) before the baseline visit. At least 4 weeks (minimum 26 days) must have passed between the last anti-VEGF pretreatment and baseline.
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:

Concomitant conditions or ocular disorders in the study eye 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 52-week study period, atrophy or fibrosis at the center of the fovea as confirmed by central reading center or structural damage 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 judgement, at screening or baseline (study eye)
Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <20/200 at screening (except when due to conditions whose surgery may improve VA, e.g. cataract)
Ocular treatments: treatment with anti-VEGF drugs for > 5 years in the study eye, pretreatment with brolucizumab at any time in the study eye, previous treatment with investigational drugs in the last 6 months, intraocular or periocular steroids at any time, macular laser photocoagulation or photodynamic therapy at any time, peripheral laser photocoagulation within 3 months prior to baseline, intraocular surgery within 3 months prior to baseline, vitreoretinal surgery at any time, aphakia with the absence of posterior capsule (study eye)
Stroke or myocardial infarction during the 6 month period prior to baseline
Systemic anti-VEGF therapy during the 3-month period prior to baseline

Other protocol-defined inclusion/exclusion criteria may apply

Study Locations

Germany
Novartis Investigative Site
Recruiting
Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
Recruiting
Frankfurt Main, 60549
Hessen
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86179
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10713
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Darmstadt, 64297
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01067
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Duesseldorf, 40225
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Homburg, 66421
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50924
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Ludwigshafen, 67063
-
Germany
Novartis Investigative Site
Recruiting
Luebeck, 23538
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Marburg, 35039
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Neubrandenburg, 17036
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89075
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
Recruiting
Frankfurt Main, 60549
Hessen
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86179
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10713
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Darmstadt, 64297
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01067
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Duesseldorf, 40225
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Homburg, 66421
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50924
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Ludwigshafen, 67063
-
Germany
Novartis Investigative Site
Recruiting
Luebeck, 23538
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Marburg, 35039
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Neubrandenburg, 17036
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89075
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Novartis Investigative Site
Recruiting
Regensburg, 93053
Bavaria
Germany
Novartis Investigative Site
Recruiting
Frankfurt Main, 60549
Hessen
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86179
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10713
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53105
-
Germany
Novartis Investigative Site
Recruiting
Darmstadt, 64297
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01067
-
Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Duesseldorf, 40225
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Hannover, 30625
-
Germany
Novartis Investigative Site
Recruiting
Heidelberg, 69120
-
Germany
Novartis Investigative Site
Recruiting
Homburg, 66421
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 50924
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04103
-
Germany
Novartis Investigative Site
Recruiting
Ludwigshafen, 67063
-
Germany
Novartis Investigative Site
Recruiting
Luebeck, 23538
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Marburg, 35039
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Muenster, 48149
-
Germany
Novartis Investigative Site
Recruiting
Neubrandenburg, 17036
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89075
-
Germany
Novartis Investigative Site
Recruiting
Wuerzburg, 97080
-
Germany
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1000
CHE
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4056
-
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3012
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1006
-
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8063
-
Switzerland
Novartis Investigative Site
Recruiting
Zurich, 8091
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1000
CHE
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4056
-
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3012
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1006
-
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8063
-
Switzerland
Novartis Investigative Site
Recruiting
Zurich, 8091
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1000
CHE
Switzerland
Novartis Investigative Site
Recruiting
Aarau, 5001
-
Switzerland
Novartis Investigative Site
Recruiting
Basel, 4056
-
Switzerland
Novartis Investigative Site
Recruiting
Bern, 3012
-
Switzerland
Novartis Investigative Site
Recruiting
Lausanne, 1006
-
Switzerland
Novartis Investigative Site
Recruiting
Zuerich, 8063
-
Switzerland
Novartis Investigative Site
Recruiting
Zurich, 8091
-
Switzerland

Contacts

Name: 
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Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

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