A Study of the Efficacy and Safety of Brolucizumab vs. Aflibercept in Patients With Visual Impairment Due to Diabetic Macular Edema

A Two-Year, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Diabetic Macular Edema

ClinicalTrials.gov Identifier: NCT03481660

Novartis Reference Number: CRTH258B2302

See if you pre-qualify

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 brolucizumab in treatment of patients with visual impairment due to diabetic macular edema (DME).

Condition 
Diabetic Macular Edema
Phase 
Phase 3
Overall status 
Active, not recruiting
Enrollment count 
361 participants
Start date 
Jul 27, 2018
Completion date 
Jul 16, 2021
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Brolucizumab
Intravitreal injection
Drug
Aflibercept
Intravitreal injection

Eligibility Criteria

Inclusion Criteria:

Written informed consent before any assessment
Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening
Medication for the management of diabetes stable within 3 months prior to randomization and is expected to remain stable during the course of the study

Exclusion Criteria:

Active proliferative diabetic retinopathy in the study eye
Active intraocular or periocular infection or active intraocular inflammation in the study eye
Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 millimeters mercury (mmHg)
Previous treatment with anti-VEGF drugs or investigational drugs in the study eye
Stroke or myocardial infarction during the 6-month period prior to baseline
Uncontrolled blood pressure defined as a systolic value ≥160 mmHg or diastolic value ≥100 mmHg

Other protocol-specified inclusion/exclusion criteria may apply

Study Locations

Belgium
Novartis Investigative Site
-
Alken, 3570
-
Belgium
Bulgaria
Novartis Investigative Site
-
Sofia, 1606
-
Bulgaria
Novartis Investigative Site
-
Sofia, 1784
-
Bulgaria
Novartis Investigative Site
-
Varna, 9000
-
Bulgaria
Czechia
Novartis Investigative Site
-
Hradec Kralove, 500 05
CZE
Czechia
Novartis Investigative Site
-
Praha 10, 100 34
-
Czechia
Novartis Investigative Site
-
Praha, 12808
-
Czechia
Denmark
Novartis Investigative Site
-
Aalborg, 9000
-
Denmark
Novartis Investigative Site
-
Roskilde, 4000
-
Denmark
Estonia
Novartis Investigative Site
-
Tallinn, 11412
-
Estonia
Novartis Investigative Site
-
Tartu, 51014
-
Estonia
France
Novartis Investigative Site
-
Bobigny cedex, 93009
Seine Saint Denis
France
Novartis Investigative Site
-
Bordeaux, 33000
-
France
Novartis Investigative Site
-
Creteil, 94000
-
France
Novartis Investigative Site
-
Dijon, 21034
-
France
Novartis Investigative Site
-
Lyon Cedex 04, 69317
-
France
Novartis Investigative Site
-
Lyon, 69275
-
France
Novartis Investigative Site
-
Marseille, F 13008
-
France
Novartis Investigative Site
-
Montauban, 82000
-
France
Novartis Investigative Site
-
Nantes Cedex 1, 44093
-
France
Novartis Investigative Site
-
Paris cedex 10, 75010
-
France
Novartis Investigative Site
-
Paris, 75015
-
France
Novartis Investigative Site
-
Rouen, 76100
-
France
Germany
Novartis Investigative Site
-
Berlin, 10713
-
Germany
Novartis Investigative Site
-
Düsseldorf, 40212
-
Germany
Novartis Investigative Site
-
Freiburg, 79106
-
Germany
Novartis Investigative Site
-
Gottingen, 37075
-
Germany
Novartis Investigative Site
-
Leipzig, 04103
-
Germany
Novartis Investigative Site
-
Muenster, 48145
-
Germany
Novartis Investigative Site
-
Ulm, 89075
-
Germany
Hungary
Novartis Investigative Site
-
Budapest, 1083
-
Hungary
Novartis Investigative Site
-
Debrecen, 4012
-
Hungary
Novartis Investigative Site
-
Nyiregyhaza, H 4400
-
Hungary
Novartis Investigative Site
-
Szeged, H 6725
-
Hungary
Novartis Investigative Site
-
Szombathely, 9700
-
Hungary
India
Novartis Investigative Site
-
Chennai, 600006
Tamil Nadu
India
Novartis Investigative Site
-
Coimbatore, 641014
Tamil Nadu
India
Novartis Investigative Site
-
Hyderabad,
Telangana
India
Novartis Investigative Site
-
Chandigarh, 160012
-
India
Novartis Investigative Site
-
New Delhi, 110029
-
India
Korea, Republic of
Novartis Investigative Site
-
Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of
Novartis Investigative Site
-
Busan, 602739
-
Korea, Republic of
Novartis Investigative Site
-
Seoul, 02841
-
Korea, Republic of
Novartis Investigative Site
-
Seoul, 05505
-
Korea, Republic of
Novartis Investigative Site
-
Seoul, 06351
-
Korea, Republic of
Novartis Investigative Site
-
Seoul, 07301
-
Korea, Republic of
Latvia
Novartis Investigative Site
-
Riga, LV 1002
-
Latvia
Lebanon
Novartis Investigative Site
-
Ashrafieh, 166830
-
Lebanon
Novartis Investigative Site
-
Beirut, 116-5311
-
Lebanon
Novartis Investigative Site
-
Beirut, 70-933
-
Lebanon
Lithuania
Novartis Investigative Site
-
Kaunas, LT 50161
LTU
Lithuania
Novartis Investigative Site
-
Vilnius, LT 08661
-
Lithuania
Malaysia
Novartis Investigative Site
-
Petaling Jaya, 46150
Selangor Darul Ehsan
Malaysia
Novartis Investigative Site
-
Shah Alam, 40000
Selangor
Malaysia
Norway
Novartis Investigative Site
-
Oslo, NO 0450
-
Norway
Poland
Novartis Investigative Site
-
Gdansk, 80 809
-
Poland
Russian Federation
Novartis Investigative Site
-
Cheboksary, 428028
-
Russian Federation
Novartis Investigative Site
-
Ekaterinburg, 620109
-
Russian Federation
Novartis Investigative Site
-
Kazan, 420066
-
Russian Federation
Novartis Investigative Site
-
Moscow, 119021
-
Russian Federation
Novartis Investigative Site
-
Moscow, 127486
-
Russian Federation
Singapore
Novartis Investigative Site
-
Singapore, 168751
-
Singapore
Novartis Investigative Site
-
Singapore, S308433
-
Singapore
Slovakia
Novartis Investigative Site
-
Banska Bystrica, 97517
-
Slovakia
Novartis Investigative Site
-
Bratislava, 82606
-
Slovakia
Novartis Investigative Site
-
Bratislava, 83301
-
Slovakia
Novartis Investigative Site
-
Poprad, 058 45
-
Slovakia
Novartis Investigative Site
-
Trencin, 91171
-
Slovakia
Sweden
Novartis Investigative Site
-
Oerebro, 701 85
-
Sweden
Switzerland
Novartis Investigative Site
-
Bern, 3012
-
Switzerland
Novartis Investigative Site
-
Zuerich, 8063
-
Switzerland
Taiwan
Novartis Investigative Site
-
Changhua, 50006
-
Taiwan
Novartis Investigative Site
-
Taichung, 40447
-
Taiwan
Novartis Investigative Site
-
Taoyuan, 33305
-
Taiwan
Turkey
Novartis Investigative Site
-
Ankara, 06100
-
Turkey
Novartis Investigative Site
-
Gaziantep, 27310
-
Turkey
Novartis Investigative Site
-
Izmir, 35340
-
Turkey
Novartis Investigative Site
-
Kocaeli, 41380
-
Turkey

Have a question?

Call 1-999-669-6682 or email [email protected]