A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
NCT ID: NCT06176352
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
280 participants
INTERVENTIONAL
2024-03-06
2026-05-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm A: Faricimab
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.
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.
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.
Arm B: Ranibizumab
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.
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.
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.
Interventions
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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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of active myopic CNV in the study eye:
1. Presence of high myopia, worse than -6 diopters of spherical equivalence
2. Antero-posterior elongation measurement greater than or equal to 26.0 mm
3. Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
4. Presence of active leakage from CNV on FFA (determined by Central Reading Centre \[CRC\])
5. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
3. 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
4. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
5. Ability to comply with the study protocol, in the Investigator's judgment
Exclusion Criteria
2. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
3. Uncontrolled blood pressure (systolic \>180 millimetres of mercury \[mmHg\], diastolic \>100 mmHg)
4. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
5. History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
6. Uncontrolled glaucoma in study eye
7. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
8. 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Beijing Hospital of Ministry of Health
Beijing, , China
Beijing Tong Ren Hospital, Capital Medical University
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Beijing Tsinghua Changgung Hospital
Beijing, , China
The Second Hospital of Jilin University
Changchun, , China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, , China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, , China
Qingdao Eye Hospital of Shandong First Medical University
Qingdao, , China
Eye & ENT Hospital of Fudan University
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
First Hospital of China Medical University
Shenyang, , China
Shanxi Eye Hospital
Taiyuan, , China
Tianjin Medical University Eye Hospital
Tianjin, , China
Eye Hospital, Wenzhou Medical University
Wenzhou, , China
Central Theater General Hospital of the Chinese People's Liberation Army
Wuhan, , China
Wuxi No.2 People's Hospital
Wuxi, , China
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an, , China
Chi De Creteil
Créteil, , France
Hopital de la croix rousse
Lyon, , France
Centre Paradis Monticelli
Marseille, , France
CHU Nantes - Hotel Dieu
Nantes, , France
Hopital Lariboisiere
Paris, , France
Fondation Rothschild
Paris, , France
Centres Ophtalmologique St Exupéry
Saint-Cyr-sur-Loire, , France
Universitatsklinikum Koln
Cologne, , Germany
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, , Germany
Knappschaftsklinikum Saar GmbH
Sulzbach, , Germany
The University of Hong Kong
Hong Kong, , Hong Kong
Hong Kong Eye Hospital
Mong Kok, , Hong Kong
Ospedale Clinicizzato SS Annunziata
Chieti, Abruzzo, Italy
Policlinico di Bari
Bari, Apulia, Italy
Ospedale Monaldi - AORN dei Colli
Napoli, Campania, Italy
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Rome, Lazio, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
Milan, Lombardy, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine
Udine, Veneto, Italy
Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.
?ód?, , Poland
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, , Poland
Centrum Medyczne UNO-MED
Krakow, , Poland
Gabinet Okulistyczny Jerzy Mackiewicz
Lublin, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, , Poland
National University Hospital
Singapore, , Singapore
Singapore Eye Research Institute
Singapore, , Singapore
Asia Pacific Eye Centre
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Yeungnam University Medical Center
Daegu, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kim's Eye Hospital
Seoul, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario de Santiago.
Santiago de Compostela, LA Coruna, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital de la Arruzafa. Servicio de Oftalmologia
Córdoba, , Spain
Oftalvist
Madrid, , Spain
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
National Taiwan University Hospital
Zhongzheng Dist., , Taiwan
Countries
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Other Identifiers
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2023-506707-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR44829
Identifier Type: -
Identifier Source: org_study_id