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

NCT06176352 | Completed Phase 3 DMC

• 2 other identifiers: CR448292023-506707-25-00
• Study Type: interventional
• Target: 280
• Locations: 11 countries
• Sites: 62

Brief Summary

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).

Conditions

Choroidal Neovascularization Secondary to Pathologic Myopia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12

  Baseline and Average of Weeks 4, 8, and 12

Secondary Outcomes (17)

• Change from Baseline in BCVA Over Time

  From Baseline through Week 48

• Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Averaged Over Weeks 4, 8, and 12

  Baseline and Average of Weeks 4, 8, and 12

• Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time

  From Baseline through Week 48

• Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time

  From Baseline through Week 48

• Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline or Achieving a BCVA of ≥84 Letters Over Time

  From Baseline through Week 48

Study Arms (2)

Arm A: Faricimab

EXPERIMENTAL

All participants randomly assigned to Arm A will receive faricimab 6 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with faricimab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.

Drug: Faricimab; Procedure: Sham Procedure

Arm B: Ranibizumab

ACTIVE COMPARATOR

All participants randomly assigned to Arm B will receive ranibizumab 0.5 mg at Day 1. Once every 4 weeks (Q4W) after Day 1, participants will receive treatment with ranibizumab on a pro re nata (PRN) basis dependent on prespecified retreatment criteria.

Drug: Ranibizumab; Procedure: Sham Procedure

Interventions

Faricimab DRUG

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.

Also known as: VABYSMO®, faricimab-svoa, RO6867461, RG7716

Arm A: Faricimab

Ranibizumab DRUG

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.

Also known as: Lucentis

Arm B: Ranibizumab

Sham Procedure 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.

Arm A: Faricimab; Arm B: Ranibizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
• Diagnosis of active myopic CNV in the study eye:
• Presence of high myopia, worse than -6 diopters of spherical equivalence
• Antero-posterior elongation measurement greater than or equal to 26.0 mm
• Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
• Presence of active leakage from CNV on FFA (determined by Central Reading Centre \[CRC\])
• Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
• BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
• Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
• Ability to comply with the study protocol, in the Investigator's judgment

You may not qualify if:

• Any major illness or major surgical procedure within 1 month before screening
• Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
• Uncontrolled blood pressure (systolic \>180 millimetres of mercury \[mmHg\], diastolic \>100 mmHg)
• Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
• History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
• Uncontrolled glaucoma in study eye
• Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
• Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (62)

Strathfield Retina Clinic

Strathfield, New South Wales, 2135, Australia

Location

Sydney Eye Hospital

Sydney, New South Wales, 2000, Australia

Location

Sydney Retina Clinic and Day Surgery

Sydney, New South Wales, 2000, Australia

Location

Centre For Eye Research Australia

East Melbourne, Victoria, 3002, Australia

Location

Beijing Hospital of Ministry of Health

Beijing, 100730, China

Location

Beijing Tong Ren Hospital, Capital Medical University

Beijing, 100730, China

Location

Peking Union Medical College Hospital

Beijing, 100730, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, 102218, China

Location

The Second Hospital of Jilin University

Changchun, 130041, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, 510060, China

Location

The 2nd Affiliated Hospital of Harbin Medical University

Harbin, 150001, China

Location

Qingdao Eye Hospital of Shandong First Medical University

Qingdao, 265299, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, 200030, China

Location

Shanghai First People's Hospital

Shanghai, 200080, China

Location

First Hospital of China Medical University

Shenyang, 110001, China

Location

Shanxi Eye Hospital

Taiyuan, 030002, China

Location

Eye Hospital, Wenzhou Medical University

Wenzhou, 325027, China

Location

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

Wuhan, China

Location

Wuxi No.2 People's Hospital

Wuxi, 214000, China

Location

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

Xi'an, China

Location

Chi De Creteil

Créteil, 94010, France

Location

Hopital de la croix rousse

Lyon, 69317, France

Location

Centre Paradis Monticelli

Marseille, 13008, France

Location

CHU Nantes - Hotel Dieu

Nantes, 44093, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Fondation Rothschild

Paris, 75940, France

Location

Centres Ophtalmologique St Exupéry

Saint-Cyr-sur-Loire, 37540, France

Location

Universitatsklinikum Koln

Cologne, 50937, Germany

Location

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

Knappschaftsklinikum Saar GmbH

Sulzbach, 66280, Germany

Location

The University of Hong Kong

Hong Kong, Hong Kong

Location

Hong Kong Eye Hospital

Mong Kok, Hong Kong

Location

Ospedale Clinicizzato SS Annunziata

Chieti, Abruzzo, 66100, Italy

Location

Policlinico di Bari

Bari, Apulia, 70124, Italy

Location

Ospedale Monaldi - AORN dei Colli

Naples, Campania, 80131, Italy

Location

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

Rome, Lazio, 00184, Italy

Location

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

Milan, Lombardy, 20100, Italy

Location

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

Udine, Veneto, 33100, Italy

Location

OFTALMIKA Sp. z o.o

Bydgoszcz, 85-631, Poland

Location

Gabinet Okulistyczny Prof Edward Wylegala

Katowice, 40-594, Poland

Location

Centrum Medyczne UNO-MED

Krakow, 31-070, Poland

Location

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

Lódz, 91-134, Poland

Location

Gabinet Okulistyczny Jerzy Mackiewicz

Lublin, 20-064, Poland

Location

Centrum Diagnostyki i Mikrochirurgii Oka LENS

Olsztyn, 10-424, Poland

Location

National University Hospital

Singapore, 119074, Singapore

Location

Singapore Eye Research Institute

Singapore, 168751, Singapore

Location

Asia Pacific Eye Centre

Singapore, 258500, Singapore

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Kim's Eye Hospital

Seoul, 07301, South Korea

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Complejo Hospitalario Universitario de Santiago.

Santiago de Compostela, LA Coruna, 15706, Spain

Location

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital de la Arruzafa. Servicio de Oftalmologia

Córdoba, 14012, Spain

Location

Oftalvist

Madrid, 28006, Spain

Location

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

National Taiwan University Hospital

Zhongzheng Dist., 10002, Taiwan

Location

MeSH Terms

Interventions

faricimab; Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 19, 2023
• Study Start: March 6, 2024
• Primary Completion: September 11, 2025
• Study Completion: May 22, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (16); DE (3); SG (4); FR (7); TW (3); PL (6); KR (5); ES (6); IT (6); AU (4); HK (2)