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

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia
• Intervention / Treatment: Drug: Faricimab; Procedure: Sham Procedure; Drug: Ranibizumab

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Strathfield, New South Wales, Australia, 2135
      • Strathfield Retina Clinic
    • Sydney, New South Wales, Australia, 2000
      • Sydney Eye Hospital
    • Sydney, New South Wales, Australia, 2000
      • Sydney Retina Clinic and Day Surgery
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Centre for Eye Research Australia
• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
  • Beijing, China, 102218
    • Beijing Tsinghua Changgung Hospital
  • Beijing, China, 100730
    • Beijing Hospital of Ministry of Health
  • Beijing, China, 100730
    • Beijing Tong Ren Hospital, Capital Medical University
  • Changchun, China, 130041
    • The Second Hospital of Jilin University
  • Guangzhou, China, 510060
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Harbin, China, 150001
    • The 2nd Affiliated Hospital of Harbin Medical University
  • Qingdao, China, 265299
    • Qingdao Eye Hospital of Shandong First Medical University
  • Shanghai, China, 200080
    • Shanghai First People's Hospital
  • Shanghai, China, 200030
    • Eye & ENT Hospital of Fudan University
  • Shenyang, China, 110001
    • First Hospital of China Medical University
  • Taiyuan, China, 030002
    • Shanxi eye hospital
  • Wenzhou, China, 325027
    • Eye Hospital, Wenzhou Medical University
  • Wuhan, China
    • Central Theater General Hospital of the Chinese People's Liberation Army
  • Wuxi, China, 214000
    • Wuxi No.2 People's Hospital
  • Xi'an, China
    • Xi'an People's Hospital (Xi'an Fourth Hospital)
• France
  • Créteil, France, 94010
    • CHI de Créteil
  • Lyon, France, 69317
    • Hôpital de la Croix Rousse
  • Marseille, France, 13008
    • Centre Paradis Monticelli
  • Nantes, France, 44093
    • CHU Nantes - Hotel Dieu
  • Paris, France, 75010
    • Hôpital Lariboisière
  • Paris, France, 75940
    • Fondation Rothschild
  • Saint-Cyr-sur-Loire, France, 37540
    • Centres Ophtalmologique St Exupéry
• Germany
  • Cologne, Germany, 50937
    • Universitätsklinikum Köln
  • Freiburg im Breisgau, Germany, 79106
    • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Sulzbach, Germany, 66280
    • Knappschaftsklinikum Saar GmbH
• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong
  • Mong Kok, Hong Kong
    • Hong Kong Eye Hospital
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66100
      • Ospedale Clinicizzato SS Annunziata
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Policlinico di Bari
  • Campania
    • Napoli, Campania, Italy, 80131
      • Ospedale Monaldi - AORN dei Colli
  • Lazio
    • Rome, Lazio, Italy, 00184
      • Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
  • Lombardy
    • Milan, Lombardy, Italy, 20100
      • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
  • Veneto
    • Udine, Veneto, Italy, 33100
      • A.O. Universitaria S. Maria Della Misericordia Di Udine
• Poland
  • ?ód?, Poland, 91-134
    • Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.
  • Bydgoszcz, Poland, 85-631
    • OFTALMIKA Sp. z o.o
  • Katowice, Poland, 40-594
    • Gabinet Okulistyczny Prof Edward Wylegala
  • Krakow, Poland, 31-070
    • Centrum Medyczne UNO-MED
  • Lublin, Poland, 20-064
    • Gabinet Okulistyczny Jerzy Mackiewicz
  • Olsztyn, Poland, 10-424
    • Centrum Diagnostyki i Mikrochirurgii Oka LENS
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 168751
    • Singapore Eye Research Institute
  • Singapore, Singapore, 258500
    • Asia Pacific Eye Centre
• South Korea
  • Daegu, South Korea, 42415
    • Yeungnam University Medical Center
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 07301
    • Kim's Eye Hospital
• Spain
  • Córdoba, Spain, 14012
    • Hospital de la Arruzafa. Servicio de Oftalmologia
  • Madrid, Spain, 28006
    • Oftalvist
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitario de Bellvitge
  • LA Coruna
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago.
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universitaria de Navarra
• Taiwan
  • New Taipei City, Taiwan, 220
    • Far Eastern Memorial Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Zhongzheng Dist., Taiwan, 10002
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia

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
6. Other protocol-defined inclusion criteria apply

Exclusion Criteria:

1. Any major illness or major surgical procedure within 1 month before screening
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
9. Other protocol-defined exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: RO6867461; RG7716; VABYSMO®; faricimab-svoa; 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.
Active Comparator: 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.	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.; 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.; Other Names: Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time	From Baseline through Week 48
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time	From Baseline through Week 48
Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48	From Baseline to Weeks 12, 24, and 48
Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48	From Baseline to Weeks 12, 24, and 48
Change from Baseline in Central Subfield Thickness (CST) of the Study Eye Averaged Over Weeks 4, 8, and 12	Baseline and Average of Weeks 4, 8, and 12
Change from Baseline in CST of the Study Eye Over Time	From Baseline through Week 48
Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48	Baseline, Weeks 12 and 48
Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48	Baseline, Weeks 12 and 48
Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48	Weeks 12 and 48
Incidence and Severity of Ocular Adverse Events	From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Incidence and Severity of Non-Ocular Adverse Events	From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study	At Baseline and from first dose until end of study (up to 48 weeks)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Actual): September 11, 2025
• Study Completion (Estimated): May 29, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Eye Diseases; Neoplastic Processes; Refractive Errors; Uveal Diseases; Choroid Diseases; Metaplasia; Myopia; Neoplasm Metastasis; Choroidal Neovascularization; Neovascularization, Pathologic; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Ranibizumab; faricimab
• Other Study ID Numbers: CR44829; 2023-506707-25-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No