Fact CheckerSign in

NCT04278417CompletedPhase 3

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

Source: ClinicalTrials.gov · Last updated 16 Oct 2025

Brief summary (registry, in English)

The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
689 (actual)
First submitted
18 Feb 2020
Start date
19 Nov 2020
Primary completion date
30 Oct 2023
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT04278417

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 689
  • From 19 Nov 2020 to the primary completion date, 30 Oct 2023
  • 110 sites in 16 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
  • Treatment with intraocular corticosteroids
  • Systemic anti-VEGF therapy at any time
    • Other protocol-defined inclusion/exclusion criteria may apply.

Other illness

  • Active infection or inflammation in the study eye
  • End stage renal disease requiring dialysis or kidney transplant

Other

  • Presence of diabetic macular edema in the study eye
  • Uncontrolled glaucoma (IOP greater than 25 mmHg)
  • Intravitreal anti-VEGF treatment within 6 months
  • Uncontrolled blood pressure

Who the study is looking for

  • Signed informed consent must be obtained prior to participation
  • Able to complete adequate fundus photographs and retinal images
  • Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
  • DM treatment stable for at least 3 months
  • PDR diagnosis with no previous PRP treatment in the study eye

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (110)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
CABAArgentinaUnknown status
-
Coordinator of this site? Confirm its status
Ciudad Autonoma de Bs AsArgentinaUnknown status
-
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
-
Coordinator of this site? Confirm its status
AlburyAustraliaUnknown status
-
Coordinator of this site? Confirm its status
LiverpoolAustraliaUnknown status
-
Coordinator of this site? Confirm its status
ParramattaAustraliaUnknown status
-
Coordinator of this site? Confirm its status
StrathfieldAustraliaUnknown status
-
Coordinator of this site? Confirm its status
BlumenauBrazilUnknown status
-
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
-
Coordinator of this site? Confirm its status
SorocabaBrazilUnknown status
-
Coordinator of this site? Confirm its status
BoisbriandCanadaUnknown status
-
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
-
Coordinator of this site? Confirm its status
QuébecCanadaUnknown status
-
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
-
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
-
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
-
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
-
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
-
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
-
Coordinator of this site? Confirm its status
NantongChinaUnknown status
-
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
-
Coordinator of this site? Confirm its status
ShantouChinaUnknown status
-
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
-
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
-
Coordinator of this site? Confirm its status
WenzhouChinaUnknown status
-
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
-
Coordinator of this site? Confirm its status
Xi’anChinaUnknown status
-
Coordinator of this site? Confirm its status
AhmedabadIndiaUnknown status
-
Coordinator of this site? Confirm its status
ChandigarhIndiaUnknown status
-
Coordinator of this site? Confirm its status
CoimbatoreIndiaUnknown status
-
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
-
Coordinator of this site? Confirm its status
TirunelveliIndiaUnknown status
-
Coordinator of this site? Confirm its status
AkitaJapanUnknown status
-
Coordinator of this site? Confirm its status
AsahikawaJapanUnknown status
-
Coordinator of this site? Confirm its status
Chiyoda-kuJapanUnknown status
-
Coordinator of this site? Confirm its status
HachiōjiJapanUnknown status
-
Coordinator of this site? Confirm its status
Kita-gunJapanUnknown status
-
Coordinator of this site? Confirm its status
KobeJapanUnknown status
-
Coordinator of this site? Confirm its status
KōriyamaJapanUnknown status
-
Coordinator of this site? Confirm its status
KurumeJapanUnknown status
-
Coordinator of this site? Confirm its status
MatsumotoJapanUnknown status
-
Coordinator of this site? Confirm its status
Meguro-kuJapanUnknown status
-
Coordinator of this site? Confirm its status
NagakuteJapanUnknown status
-
Coordinator of this site? Confirm its status
NagoyaJapanUnknown status
-
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
-
Coordinator of this site? Confirm its status
SakuraJapanUnknown status
-
Coordinator of this site? Confirm its status
ShimotsukeJapanUnknown status
-
Coordinator of this site? Confirm its status
TsuJapanUnknown status
-
Coordinator of this site? Confirm its status
Yoshida-gunJapanUnknown status
-
Coordinator of this site? Confirm its status
Bundang GuSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
Ciudad deMexicoUnknown status
-
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status
-
Coordinator of this site? Confirm its status
TijuanaMexicoUnknown status
-
Coordinator of this site? Confirm its status
MakatiPhilippinesUnknown status
-
Coordinator of this site? Confirm its status
PasigPhilippinesUnknown status
Emanuelli Research and Development Center, LLC
Coordinator of this site? Confirm its status
AreciboPuerto RicoUnknown status
-
Coordinator of this site? Confirm its status
CheboksaryRussiaUnknown status
-
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
-
Coordinator of this site? Confirm its status
OmskRussiaUnknown status
-
Coordinator of this site? Confirm its status
SterlitamakRussiaUnknown status
-
Coordinator of this site? Confirm its status
UlyanovskRussiaUnknown status
-
Coordinator of this site? Confirm its status
YekaterinburgRussiaUnknown status
-
Coordinator of this site? Confirm its status
Hualien CityTaiwanUnknown status
-
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
Texan Eye P A
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Austin Retina Associates
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Retina and Vitreous of Texas
Coordinator of this site? Confirm its status
BellaireUnited StatesUnknown status
Retina Consultants TX Rsrch Ctr
Coordinator of this site? Confirm its status
BellaireUnited StatesUnknown status
Retina- Vitreous Assoc Medical Group
Coordinator of this site? Confirm its status
Beverly HillsUnited StatesUnknown status
Retina Associates of Cleveland
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Advanced Research LLC
Coordinator of this site? Confirm its status
Deerfield BeachUnited StatesUnknown status
Rand Eye Institute
Coordinator of this site? Confirm its status
Deerfield BeachUnited StatesUnknown status
Retina Associates
Coordinator of this site? Confirm its status
ElmhurstUnited StatesUnknown status
Erie Retinal Surgery
Coordinator of this site? Confirm its status
ErieUnited StatesUnknown status
Pinnacle Research Institute
Coordinator of this site? Confirm its status
Fort LauderdaleUnited StatesUnknown status
National Ophthalmic Research Institute
Coordinator of this site? Confirm its status
Fort MyersUnited StatesUnknown status
Texas Retina Associates
Coordinator of this site? Confirm its status
Fort WorthUnited StatesUnknown status
Retina Consultants of Orange County
Coordinator of this site? Confirm its status
FullertonUnited StatesUnknown status
Cumberland Valley Retina Consultants
Coordinator of this site? Confirm its status
HagerstownUnited StatesUnknown status
Valley Retina Institute PA
Coordinator of this site? Confirm its status
HarlingenUnited StatesUnknown status
Retina Consultants of Houston PA
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Salehi Retina Institute
Coordinator of this site? Confirm its status
Huntington BeachUnited StatesUnknown status
Midwest Eye Institute
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
University of Mississippi Med Ctr
Coordinator of this site? Confirm its status
JacksonUnited StatesUnknown status
Florida Retina Institute
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Southeastern Retina Associates, P.C.
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
Charleston Neuroscience Institute
Coordinator of this site? Confirm its status
LadsonUnited StatesUnknown status
Blue Oc Clin Res at Palm Bch Eye Ct
Coordinator of this site? Confirm its status
LakelandUnited StatesUnknown status
Retina Associates PA
Coordinator of this site? Confirm its status
LenexaUnited StatesUnknown status
MedEye Associates
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
John-Kenyon American Eye Institute PC
Coordinator of this site? Confirm its status
New AlbanyUnited StatesUnknown status
Virginia Eye Consultants
Coordinator of this site? Confirm its status
NorfolkUnited StatesUnknown status
Dean McGee Eye Institute
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Florida Retina Institute
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Eye Center of North Florida
Coordinator of this site? Confirm its status
Panama CityUnited StatesUnknown status
Fort Lauderdale Eye Institute
Coordinator of this site? Confirm its status
PlantationUnited StatesUnknown status
Retina Consultants of Southern California
Coordinator of this site? Confirm its status
RedlandsUnited StatesUnknown status
Retina Associates of South Texas PA
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Medical Center Opthamology Assoc
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Cascade Medical Research Institute
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
Premiere Practice Management LLC
Coordinator of this site? Confirm its status
TorranceUnited StatesUnknown status
Lundquist Inst BioMed at Harbor
Coordinator of this site? Confirm its status
TorranceUnited StatesUnknown status
Retina Associates SW
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status
Miramar Eye Specialists
Coordinator of this site? Confirm its status
VenturaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
-
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status
-
Coordinator of this site? Confirm its status
IzmirTurkey (Türkiye)Unknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.