Completed

NCT Number: NCT06176352

A 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).

Completed

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Key information

Conditions

Choroidal Neovascularization Secondary to Pathologic Myopia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Strathfield Retina Clinic, Strathfield, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
Other protocol-defined inclusion criteria apply

Exclusion criteria

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
Other protocol-defined exclusion criteria apply

Treatment and study plan

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.

Other names: VABYSMO®, faricimab-svoa, RO6867461, RG7716

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.

Other names: Lucentis

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.

Primary outcomes

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

Secondary outcomes

Change from Baseline in BCVA Over Time

Time frame: From Baseline through Week 48
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Averaged Over Weeks 4, 8, and 12

Time frame: Baseline and Average of Weeks 4, 8, and 12
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time

Time frame: From Baseline through Week 48
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time

Time frame: From Baseline through Week 48
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline or Achieving a BCVA of ≥84 Letters Over Time

Time frame: From Baseline through Week 48
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time

Time frame: From Baseline through Week 48
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time

Time frame: From Baseline through Week 48
Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48

Time frame: From Baseline to Weeks 12, 24, and 48
Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48

Time frame: 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

Time frame: Baseline and Average of Weeks 4, 8, and 12
Change from Baseline in CST of the Study Eye Over Time

Time frame: From Baseline through Week 48
Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48

Time frame: Baseline, Weeks 12 and 48
Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48

Time frame: Baseline, Weeks 12 and 48
Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48

Time frame: Weeks 12 and 48
Incidence and Severity of Ocular Adverse Events

Time frame: 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

Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: POYANG

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2026
First posted: Dec 19, 2023
Registry last updated: Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed

A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.

NCT02034006

Choroid Diseases, Choroidal Neovascularization

Ancona, AN, Italy

View Trial Details

Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Who can participate

Treatment and study plan

Faricimab

ranibizumab

Sham Procedure

Primary outcomes

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

Secondary outcomes

Change from Baseline in BCVA Over Time

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

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

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

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

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

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

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

Number of Intravitreal Injections Received 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

Change from Baseline in CST of the Study Eye Over Time

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

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

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

Incidence and Severity of Ocular Adverse Events

Incidence and Severity of Non-Ocular Adverse Events

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

Sponsors and collaborators

Lead sponsor

Registry information

Official study title

Important dates

Related clinical trials

A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia.