A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

March 6, 2024

Primary Completion Date

September 11, 2025

Study Completion Date

May 29, 2026

Conditions
Choroidal Neovascularization Secondary to Pathologic Myopia
Interventions
DRUG

Faricimab

Faricimab 6 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.

DRUG

Ranibizumab

Ranibizumab 0.5 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.

PROCEDURE

Sham Procedure

The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Participants will undergo the sham procedure at study visits where no study drug is to be administered, in order to maintain masking.

Trial Locations (63)

220

Far Eastern Memorial Hospital, New Taipei City

2000

Sydney Eye Hospital, Sydney

Sydney Retina Clinic and Day Surgery, Sydney

2135

Strathfield Retina Clinic, Strathfield

3002

Centre For Eye Research Australia, East Melbourne

10002

National Taiwan University Hospital, Zhongzheng Dist.

11217

Taipei Veterans General Hospital, Taipei

13008

Centre Paradis Monticelli, Marseille

14012

Hospital de la Arruzafa. Servicio de Oftalmologia, Córdoba

15706

Complejo Hospitalario Universitario de Santiago., Santiago de Compostela

20100

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena, Milan

28006

Oftalvist, Madrid

28222

Hospital Universitario Puerta de Hierro, Majadahonda

31008

Clinica Universitaria de Navarra, Pamplona

33100

A.O. Universitaria S. Maria Della Misericordia Di Udine, Udine

37540

Centres Ophtalmologique St Exupéry, Saint-Cyr-sur-Loire

42415

Yeungnam University Medical Center, Daegu

44093

CHU Nantes - Hôtel Dieu, Nantes

50937

Universitätsklinikum Köln, Cologne

66100

Ospedale Clinicizzato SS Annunziata, Chieti

66280

Knappschaftsklinikum Saar GmbH, Sulzbach

69317

Hopital de la croix rousse, Lyon

70124

Policlinico di Bari, Bari

75010

Hopital Lariboisiere, Paris

75940

Fondation Rothschild, Paris

79106

Universitätsklinikum Freiburg, Klinik für Augenheilkunde, Freiburg im Breisgau

80131

Ospedale Monaldi - AORN dei Colli, Napoli

94010

Chi De Creteil, Créteil

100730

Beijing Hospital of Ministry of Health, Beijing

Beijing Tong Ren Hospital, Capital Medical University, Beijing

Peking Union Medical College Hospital, Beijing

102218

Beijing Tsinghua Changgung Hospital, Beijing

110001

First Hospital of China Medical University, Shenyang

119074

National University Hospital, Singapore

130041

The Second Hospital of Jilin University, Changchun

150001

The 2nd Affiliated Hospital of Harbin Medical University, Harbin

168751

Singapore Eye Research Institute, Singapore

200030

Eye & ENT Hospital of Fudan University, Shanghai

200080

Shanghai First People's Hospital, Shanghai

214000

Wuxi No.2 People's Hospital, Wuxi

258500

Asia Pacific Eye Centre, Singapore

265299

Qingdao Eye Hospital of Shandong First Medical University, Qingdao

300070

Tianjin Medical University Eye Hospital, Tianjin

308433

Tan Tock Seng Hospital, Singapore

325027

Eye Hospital, Wenzhou Medical University, Wenzhou

510060

Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou

030002

Shanxi Eye Hospital, Taiyuan

Unknown

Central Theater General Hospital of the Chinese People's Liberation Army, Wuhan

Xi'an People's Hospital (Xi'an Fourth Hospital), Xi'an

The University of Hong Kong, Hong Kong

Hong Kong Eye Hospital, Mong Kok

00184

Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico, Rome

91-134

Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o., ?ód?

85-631

OFTALMIKA Sp. z o.o, Bydgoszcz

40-594

Gabinet Okulistyczny Prof Edward Wylegala, Katowice

31-070

Centrum Medyczne UNO-MED, Krakow

20-064

Gabinet Okulistyczny Jerzy Mackiewicz, Lublin

10-424

Centrum Diagnostyki i Mikrochirurgii Oka LENS, Olsztyn

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

07301

Kim's Eye Hospital, Seoul

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY