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Choroidal Neovascularization Secondary to Pathologic MyopiaPhase 3POYANGNCT06176352

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

A Phase 3 study testing Faricimab and Ranibizumab in people with Choroidal Neovascularization Secondary to Pathologic Myopia, run by Hoffmann-La Roche at 63 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Faricimab and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
280 participants
Where
63 sitesin 11 countries
Study dates
6 Mar 2024to 22 May 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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])
Show all 11Show fewer
  • 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
  • Other protocol-defined inclusion criteria apply

Who cannot join

  • 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
Show all 9Show fewer
  • 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
  • Other protocol-defined exclusion criteria apply

Trial locations and contacts

63 sites in 11 countries.

63 sites in 11 countries

China17 sites

  • Beijing Hospital of Ministry of Health

    Beijing, 100730

  • Beijing Tong Ren Hospital, Capital Medical University

    Beijing, 100730

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Beijing Tsinghua Changgung Hospital

    Beijing, 102218

  • The Second Hospital of Jilin University

    Changchun, 130041

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060

  • The 2nd Affiliated Hospital of Harbin Medical University

    Harbin, 150001

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 265299

  • Eye & ENT Hospital of Fudan University

    Shanghai, 200030

  • Shanghai First People's Hospital

    Shanghai, 200080

  • First Hospital of China Medical University

    Shenyang, 110001

  • Shanxi Eye Hospital

    Taiyuan, 030002

  • Tianjin Medical University Eye Hospital

    Tianjin, 300070

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, 325027

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

    Wuhan

  • Wuxi No.2 People's Hospital

    Wuxi, 214000

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

    Xi'an

Other trials in China

France7 sites

  • Chi De Creteil

    Créteil, 94010

  • Hopital de la croix rousse

    Lyon, 69317

  • Centre Paradis Monticelli

    Marseille, 13008

  • CHU Nantes - Hotel Dieu

    Nantes, 44093

  • Hopital Lariboisiere

    Paris, 75010

  • Fondation Rothschild

    Paris, 75940

  • Centres Ophtalmologique St Exupéry

    Saint-Cyr-sur-Loire, 37540

Other trials in France

Italy6 sites

  • Policlinico di Bari

    Bari, Apulia, 70124

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66100

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

    Milan, Lombardy, 20100

  • Ospedale Monaldi - AORN dei Colli

    Naples, Campania, 80131

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

    Rome, Lazio, 00184

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

    Udine, Veneto, 33100

Other trials in Italy

Poland6 sites

  • OFTALMIKA Sp. z o.o

    Bydgoszcz, 85-631

  • Gabinet Okulistyczny Prof Edward Wylegala

    Katowice, 40-594

  • Centrum Medyczne UNO-MED

    Krakow, 31-070

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

    Lódz, 91-134

  • Gabinet Okulistyczny Jerzy Mackiewicz

    Lublin, 20-064

  • Centrum Diagnostyki i Mikrochirurgii Oka LENS

    Olsztyn, 10-424

Other trials in Poland

Spain6 sites

  • Hospital de la Arruzafa. Servicio de Oftalmologia

    Córdoba, 14012

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Oftalvist

    Madrid, 28006

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Complejo Hospitalario Universitario de Santiago.

    Santiago de Compostela, LA Coruna, 15706

Other trials in Spain

South Korea5 sites

  • Yeungnam University Medical Center

    Daegu, 42415

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Kim's Eye Hospital

    Seoul, 07301

Other trials in South Korea

Australia4 sites

  • Centre For Eye Research Australia

    East Melbourne, Victoria, 3002

  • Strathfield Retina Clinic

    Strathfield, New South Wales, 2135

  • Sydney Eye Hospital

    Sydney, New South Wales, 2000

  • Sydney Retina Clinic and Day Surgery

    Sydney, New South Wales, 2000

Other trials in Australia

Singapore4 sites

  • National University Hospital

    Singapore, 119074

  • Singapore Eye Research Institute

    Singapore, 168751

  • Asia Pacific Eye Centre

    Singapore, 258500

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

Germany3 sites

  • Universitatsklinikum Koln

    Cologne, 50937

  • Universitätsklinikum Freiburg, Klinik für Augenheilkunde

    Freiburg im Breisgau, 79106

  • Knappschaftsklinikum Saar GmbH

    Sulzbach, 66280

Other trials in Germany

Taiwan3 sites

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Taipei Veterans General Hospital

    Taipei, 11217

  • National Taiwan University Hospital

    Zhongzheng Dist., 10002

Other trials in Taiwan

Hong Kong2 sites

  • The University of Hong Kong

    Hong Kong

  • Hong Kong Eye Hospital

    Mong Kok

Other trials in Hong Kong

About this study

Official title: 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).

Being tested
Faricimab, Ranibizumab, Sham Procedure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FaricimabDrug

    Also called VABYSMO®, faricimab-svoa, RO6867461, RG7716

    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.

  • RanibizumabDrug

    Also called Lucentis

    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 ProcedureProcedure or surgery

    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.

Study groups in NCT06176352
Study groupRoleWhat they receive
Arm A: FaricimabExperimentalAll 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.
Receives: Drug: Faricimab; Procedure: Sham Procedure
Arm B: RanibizumabActive comparatorAll 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.
Receives: Drug: Ranibizumab; Procedure: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline and Average of Weeks 4, 8, and 12

Secondary outcomes (17)

  1. Change from Baseline in BCVA Over Time

    Measured: From Baseline through Week 48

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

    Measured: Baseline and Average of Weeks 4, 8, and 12

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

    Measured: From Baseline through Week 48

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

    Measured: From Baseline through Week 48

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

    Measured: From Baseline through Week 48

  6. Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time

    Measured: From Baseline through Week 48

  7. Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time

    Measured: From Baseline through Week 48

  8. Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48

    Measured: From Baseline to Weeks 12, 24, and 48

  9. Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48

    Measured: From Baseline to Weeks 12, 24, and 48

  10. Change from Baseline in Central Subfield Thickness (CST) of the Study Eye Averaged Over Weeks 4, 8, and 12

    Measured: Baseline and Average of Weeks 4, 8, and 12

  11. Change from Baseline in CST of the Study Eye Over Time

    Measured: From Baseline through Week 48

  12. Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48

    Measured: Baseline, Weeks 12 and 48

  13. Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48

    Measured: Baseline, Weeks 12 and 48

  14. Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48

    Measured: Weeks 12 and 48

  15. Incidence and Severity of Ocular Adverse Events

    Measured: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)

  16. Incidence and Severity of Non-Ocular Adverse Events

    Measured: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)

  17. Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study

    Measured: At Baseline and from first dose until end of study (up to 48 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2023
  2. Study start6 Mar 2024
  3. Primary completion22 May 2026
  4. Study completion22 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
280 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06176352
Sponsor's protocol ID
CR44829
Other IDs
2023-506707-25-00, 2023
Acronym
POYANG
Status last verified
Jul 2026
First submitted
11 Dec 2023
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faricimab and Ranibizumab in people with Choroidal Neovascularization Secondary to Pathologic Myopia, run by Hoffmann-La Roche at 63 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in China, France, Italy, Poland, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12 (time frame: Baseline and Average of Weeks 4, 8, and 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06176352.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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