Who is sponsoring NCT03386474?

NCT03386474 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT03386474?

Interventions in NCT03386474: Brolucizumab 6 mg, Aflibercept 2 mg.

What condition does NCT03386474 study?

NCT03386474 studies Neovascular Age-related Macular Degeneration.

Is NCT03386474 still recruiting?

NCT03386474 is currently completed. Last updated 5 January 2021.

Are results published for NCT03386474?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-01-05 · How we verify

NCT03386474

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD

Completed Phase 3 Results posted Last updated 5 January 2021

What this trial tests

Phase 3 trial testing Brolucizumab 6 mg in Neovascular Age-related Macular Degeneration in 151 participants. Completed in 6 September 2018.

Timeline

15 January 2018

Primary endpoint
6 September 2018

6 September 2018

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	151
Start date	15 January 2018
Primary completion	6 September 2018
Estimated completion	6 September 2018
Sites	65 locations across Puerto Rico, United States

Drugs / interventions tested

Brolucizumab 6 mg — full drug profile →
Aflibercept 2 mg — full drug profile →

Conditions studied

Neovascular Age-related Macular Degeneration — all drugs for Neovascular Age-related Macular Degeneration →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

50 and older, any sex, with Neovascular Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events Primary · Up to Week 24

Number of participants with ocular and non-ocular treatment emergent events with the new formulation brolucizumab 6 mg in this extension trial up to week 24 vs. the corresponding last 6 months of brolucizumab treatment in the Core trial \>= 2%. Safety assessment of the new formulation brolucizumab 6 mg was based on a within-patient comparison with the last 6 months of corresponding Core safety data. Missing brolucizumab data were imputed using last observation carried forward (LOCF).

Ocular AEs

Group	Value	95% CI
Brolucizumab - Overall Extension Study	20
Brolucizumab Overall Last 6 Months From Core Study	25

Non-Ocular AEs

Group	Value	95% CI
Brolucizumab - Overall Extension Study	51
Brolucizumab Overall Last 6 Months From Core Study	50

Change of Loss in BCVA of 15 Letters or More From Extension Baseline at Each Post-baseline Visit Secondary · Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data presented descriptively for only brolucizumab in line with study objective. No formal

exWeek 4 (>=15 letters loss)

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	2
Brolucizumab 6 mg - 6 mg in Core Study	0
Brolucizumab - Overall Extension Study	2

exWeek 8 (>=15 letters loss)

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	4
Brolucizumab 6 mg - 6 mg in Core Study	0
Brolucizumab - Overall Extension Study	4

exWeek 12 (>=15 letters loss)

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	4
Brolucizumab 6 mg - 6 mg in Core Study	0
Brolucizumab - Overall Extension Study	4

exWeek 16 (>=15 letters loss)

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	6
Brolucizumab 6 mg - 6 mg in Core Study	0
Brolucizumab - Overall Extension Study	6

exWeek 20 (>=15 letters loss)

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	4
Brolucizumab 6 mg - 6 mg in Core Study	0
Brolucizumab - Overall Extension Study	4

exWeek 24 (>=15 letters loss)

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	3
Brolucizumab 6 mg - 6 mg in Core Study	0
Brolucizumab - Overall Extension Study	3

Change in BCVA From Extension Baseline at Each Post-baseline Visit Secondary · Extension baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Best-corrected visual acuity for the study eye was tested at all study visits in a sitting position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing protocol at an initial testing distance of 4 meters. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective

exWeek 4

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-1.3	± 6.26
Brolucizumab 6 mg - 6 mg in Core Study	0.5	± 3.81
Brolucizumab - Overall Extension Study	-0.5	± 5.42

exWeek 8

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-1.7	± 6.90
Brolucizumab 6 mg - 6 mg in Core Study	-0.4	± 4.29
Brolucizumab - Overall Extension Study	-1.2	± 5.96

exWeek 12

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-2.7	± 7.73
Brolucizumab 6 mg - 6 mg in Core Study	-0.3	± 5.17
Brolucizumab - Overall Extension Study	-1.7	± 6.84

exWeek 16

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-3.9	± 8.42
Brolucizumab 6 mg - 6 mg in Core Study	0.8	± 5.36
Brolucizumab - Overall Extension Study	-1.9	± 7.63

exWeek 20

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-3.4	± 7.66
Brolucizumab 6 mg - 6 mg in Core Study	0.5	± 7.34
Brolucizumab - Overall Extension Study	-1.8	± 7.75

exWeek 24

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-2.0	± 8.17
Brolucizumab 6 mg - 6 mg in Core Study	0.3	± 6.79
Brolucizumab - Overall Extension Study	-1.0	± 7.67

Patients With Positive q12w Treatment Status at Week 20 Secondary · Week 20

The estimate for the proportion of patients with a positive q12w treatment status at Week 24 was derived from Kaplan Meier time-to-event analyses for the event 'first q8w-need'. The outcome of the Kaplan-Meier analysis was estimated probability for maintaining on q12w up to the Disease Activity Assessment (DAA) at exWeek 20. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension tri

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	63.3
Brolucizumab 6 mg- 6 mg in Core Study	63.1
Brolucizumab - Overall Extension Study	63.3

Change in Central Sub-Field Thickness (CSFT) From Extension Baseline at Each Post-baseline Visit Secondary · Extension Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24

Measurement of the central subfield thickness of the retina was assessed using Optical Coherence Tomography (OCT) at each visit for the study eye. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the extension trial. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned. Missing brolucizumab data were imputed using

exWeek 4

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-19.2	± 39.29
Brolucizumab 6 mg- 6 mg in Core Study	-17.5	± 40.76
Brolucizumab - Overall Extension Study	-18.5	± 39.74

exWeek 8

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-6.3	± 25.47
Brolucizumab 6 mg- 6 mg in Core Study	-18.9	± 31.74
Brolucizumab - Overall Extension Study	-11.6	± 28.82

exWeek 12

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-17.9	± 43.07
Brolucizumab 6 mg- 6 mg in Core Study	-28.9	± 48.80
Brolucizumab - Overall Extension Study	-22.5	± 45.66

exWeek 16

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-7.8	± 31.94
Brolucizumab 6 mg- 6 mg in Core Study	-11.7	± 39.83
Brolucizumab - Overall Extension Study	-9.4	± 35.35

exWeek 20

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-10.1	± 59.04
Brolucizumab 6 mg- 6 mg in Core Study	-15.3	± 46.20
Brolucizumab - Overall Extension Study	-12.3	± 53.84

exWeek 24

Group	Value	95% CI
Brolucizumab 6 mg - 3 mg in Core Study	-19.8	± 37.67
Brolucizumab 6 mg- 6 mg in Core Study	-24.6	± 42.10
Brolucizumab - Overall Extension Study	-21.8	± 39.47

Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status for Brolucuzumab 6 mg in Extension Secondary · Extension Baseline, Week 8, Week 16, Week 24

Positive integrated anti-drug antibodies (ADA) status is defined as induced ADA status with ADA negative at pre-dose and a post-dose titer value of greater than or equal to 30 at any time point or boosted ADA status with ADA positive at pre-dose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point. Outcome measure was prespecified for brolucizumab arm only. Neither the patient selection process nor expected sample sizes supported a valid comparison between aflibercept and brolucizumab. The aflibercept arm was included only to maintain the masking in the exten

Group	Value	95% CI
Brolucizumab - Overall Extension Study	54

Adverse events — posted to ClinicalTrials.gov

Time frame: From first treatment in the extension study, through study completion, to an average of 24 weeks. Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 6 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brolucizumab 6mg Overall Extension Study

Serious: 7/107 (7%)

Deaths: 1/107

Brolucizumab Overall Last 6 Months Core Study

Serious: 7/107 (7%)

Deaths: 0/107

Aflibercept 2 mg

Serious: 10/43 (23%)

Deaths: 0/43

Serious adverse events (31 terms)

Reaction	System	Brolucizumab 6mg Overall E…	Brolucizumab Overall Last …	Aflibercept 2 mg
Syncope	Nervous system disorders	—	—	—
Anaemia macrocytic	Blood and lymphatic system disorders	—	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—
Left ventricular failure	Cardiac disorders	—	—	—
Retinal artery occlusion - Study eye	Eye disorders	—	—	—
Retinal vein occlusion - Study eye	Eye disorders	—	—	—
Multiple organ dysfunction syndrome	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Bile duct stone	Hepatobiliary disorders	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Influenza	Infections and infestations	—	—	—
Necrotising fasciitis	Infections and infestations	—	—	—
Osteomyelitis	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—
Femur fracture	Injury, poisoning and procedural complications	—	—	—
Patella fracture	Injury, poisoning and procedural complications	—	—	—
Pubis fracture	Injury, poisoning and procedural complications	—	—	—
Malnutrition	Metabolism and nutrition disorders	—	—	—
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	Brolucizumab 6mg Overall E…	Brolucizumab Overall Last …	Aflibercept 2 mg
Urinary tract infection	Infections and infestations	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Cataract - Fellow eye	Eye disorders	—	—	—
Neovascular age-related macular degeneration - Fellow eye	Eye disorders	—	—	—
Haematuria	Renal and urinary disorders	—	—	—

Most-reported serious reactions: Syncope, Anaemia macrocytic, Lymphadenopathy, Cardiac failure congestive, Left ventricular failure, Retinal artery occlusion - Study eye, Retinal vein occlusion - Study eye, Multiple organ dysfunction syndrome.

Data from ClinicalTrials.gov NCT03386474 adverse events section.

Sponsor's own description

The purpose of this extension study was to assess the safety and efficacy of the new formulation of brolucizumab 6 mg ophthalmic solution when given to the same patients who received brolucizumab in the core trial CRTH258A2301 (also known as CRTH258-C002). The medical condition treated in the core and extension trials was neo-vascular age-related macular degeneration (nAMD).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

A comprehensive comparison between camelid nanobodies and single chain variable fragments.
Asaadi Y, Jouneghani FF, Janani S, Rahbarizadeh F. · · 2021 · cited 123× · PMID 34863296 · DOI 10.1186/s40364-021-00332-6
Recent Advances in Age-Related Macular Degeneration Therapies.
Fabre M, Mateo L, Lamaa D, Baillif S, et al · · 2022 · cited 68× · PMID 36014339 · DOI 10.3390/molecules27165089
The Efficacy and Safety of Brolucizumab for the Treatment of nAMD: A Systematic Review and Meta-Analysis.
Chuan J, Liu L, Feng Y, Wang M, et al · · 2022 · cited 2× · PMID 35645802 · DOI 10.3389/fphar.2022.890732
Efficacy and safety of Brolucizumab for neovascular age-related macular degeneration: a systematic review and meta-analysis.
Dou R, Jiang J. · · 2024 · PMID 38915383 · DOI 10.7717/peerj.17561

Verify or expand the search:

Other trials of Brolucizumab 6 mg

Trials testing the same drug.

NCT04278417 — Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Dia · Phase 3 · completed
NCT04005352 — Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen ( · Phase 3 · completed
NCT03810313 — Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular E · Phase 3 · terminated
NCT03802630 — Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular E · Phase 3 · terminated

Other recruiting trials for Neovascular Age-related Macular Degeneration

Currently open trials in the same condition.

NCT07275840 — A Study to Evaluate the Efficacy and Safety of IBI302inSubjects With nAMD · Phase 2 · recruiting
NCT06847542 — A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD · Phase 3 · recruiting
NCT07053358 — Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients · EARLY_PHASE1 · recruiting
NCT06680817 — A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study) · recruiting
NCT06495918 — Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects With Neovascular Age- R · Phase 3 · active not recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03386474 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 5 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03386474.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing