Choroidal Neovascularization Secondary to Pathologic Myopia Clinical Trial
— POYANGOfficial 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).
| Status | Recruiting |
| Enrollment | 280 |
| Est. completion date | November 1, 2026 |
| Est. primary completion date | February 2, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Centre For Eye Research Australia | East Melbourne | Victoria |
| Australia | South West Retina | Liverpool | New South Wales |
| Australia | Retina Specialists Victoria | Rowville | Victoria |
| Australia | 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 |
| China | Beijing Hospital of Ministry of Health; ophthalmology department | Beijing | |
| China | Beijing Tong Ren Hospital, Capital Medical University | Beijing | |
| China | Beijing Tsinghua Changgung Hospital | Beijing City | |
| China | Peking Union Medical College Hospital; Pharmacy | Beijing City | |
| China | The Second Hospital of Jilin University | Changchun | |
| China | Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou City | |
| China | The 2nd Affiliated Hospital of Harbin Medical University | Harbin | |
| China | Qingdao Eye Hospital of Shandong First Medical University | Qingdao | |
| China | Shanghai First People's Hospital | Shanghai | |
| China | Eye & ENT Hospital of Fudan University | Shanghai City | |
| China | First Hospital of China Medical University | Shenyang | |
| China | Shanxi Eye Hospital | Taiyuan City | |
| China | Tianjin Medical University Eye Hospital | Tianjin City | |
| China | Eye Hospital, Wenzhou Medical University | Wenzhou City | |
| China | Central Theater General Hospital of the Chinese People's Liberation Army | Wuhan | |
| China | Wuxi No.2 People's Hospital | Wuxi | |
| France | Chi De Creteil; Ophtalmologie | Creteil | |
| France | Hopital de la croix rousse; Ophtalmologie | Lyon cedex | |
| France | Centre Paradis Monticelli; Ophtalmologie | Marseille | |
| France | CHNO des Quinze Vingts; Ophtalmologie | Paris | |
| France | Hopital Lariboisiere; Ophtalmologie | Paris | |
| Germany | Universitätsklinikum Freiburg, Klinik für Augenheilkunde | Freiburg | |
| Germany | Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde | Göttingen | |
| Germany | Universitätsklinikum Köln; Augenklinik | Köln | |
| Germany | Universitätsklinikum Münster; Augenheilkunde | Münster | |
| Germany | Knappschaftsklinikum Saar GmbH; Augenklinik Sulzbach | Sulzbach | |
| Hong Kong | Hong Kong Eye Hospital; CUHK Eye Centre | Mongkok | |
| Italy | Ospedale Clinicizzato SS Annunziata; Clinica Oftalmologica | Chieti | Abruzzo |
| Italy | Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica | Milano | Lombardia |
| Italy | Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico | Roma | Lazio |
| Korea, Republic of | Asan Medical Center | Seoul | |
| Korea, Republic of | Kim's Eye Hospital | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System | Seoul | |
| 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 | |
| Singapore | Singapore Eye Research Institute | Singapore | |
| Spain | Oftalvist; Servicio de oftalmologia | Madrid | |
| Taiwan | Far Eastern Memorial Hospital; Ophthalmology | New Taipei City | |
| Taiwan | Taipei Veterans General Hospital; Ophthalmology | Taipei | |
| Taiwan | National Taiwan University Hospital; Ophthalmology | Zhongzheng Dist. |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
Australia, China, France, Germany, Hong Kong, Italy, Korea, Republic of, Poland, Singapore, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Change from Baseline in BCVA Over Time | From Baseline through Week 48 | ||
| Secondary | 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 | ||
| Secondary | Percentage of Participants Gaining =15 Letters in BCVA from Baseline Over Time | From Baseline through Week 48 | ||
| Secondary | Percentage of Participants Avoiding a Loss of =15 Letters in BCVA from Baseline Over Time | From Baseline through Week 48 | ||
| Secondary | Percentage of Participants Gaining =15 Letters in BCVA from Baseline or Achieving a BCVA of =84 Letters Over Time | From Baseline through Week 48 | ||
| Secondary | Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time | From Baseline through Week 48 | ||
| Secondary | Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time | From Baseline through Week 48 | ||
| Secondary | Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48 | From Baseline to Weeks 12, 24, and 48 | ||
| Secondary | Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48 | From Baseline to Weeks 12, 24, and 48 | ||
| Secondary | 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 | ||
| Secondary | Change from Baseline in CST of the Study Eye Over Time | From Baseline through Week 48 | ||
| Secondary | Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48 | Baseline, Weeks 12 and 48 | ||
| Secondary | Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48 | Baseline, Weeks 12 and 48 | ||
| Secondary | Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48 | Weeks 12 and 48 | ||
| Secondary | Incidence and Severity of Ocular Adverse Events | From first dose until 35 days after the last dose of study treatment (up to 48 weeks) | ||
| Secondary | 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) | ||
| Secondary | 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) |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02034006 -
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.
|
Phase 3 |