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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506707-25-00 | Registry Identifier | EU CT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Faricimab | Experimental | 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. |
|
| Arm B: Ranibizumab | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
Diagnosis of active myopic CNV in the study eye:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strathfield Retina Clinic | Strathfield | New South Wales | 2135 | Australia | ||
| Sydney Eye Hospital |
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
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|
| 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. |
|
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| 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. |
|
| 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) |
| Sydney |
| New South Wales |
| 2000 |
| Australia |
| Sydney Retina Clinic and Day Surgery | Sydney | New South Wales | 2000 | Australia |
| Centre For Eye Research Australia | East Melbourne | Victoria | 3002 | Australia |
| Beijing Hospital of Ministry of Health | Beijing | 100730 | China |
| Beijing Tong Ren Hospital, Capital Medical University | Beijing | 100730 | China |
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| Beijing Tsinghua Changgung Hospital | Beijing | 102218 | China |
| The Second Hospital of Jilin University | Changchun | 130041 | China |
| Zhongshan Ophthalmic Center, Sun Yat-sen University | Guangzhou | 510060 | China |
| The 2nd Affiliated Hospital of Harbin Medical University | Harbin | 150001 | China |
| Qingdao Eye Hospital of Shandong First Medical University | Qingdao | 265299 | China |
| Eye & ENT Hospital of Fudan University | Shanghai | 200030 | China |
| Shanghai First People's Hospital | Shanghai | 200080 | China |
| First Hospital of China Medical University | Shenyang | 110001 | China |
| Shanxi Eye Hospital | Taiyuan | 030002 | China |
| Eye Hospital, Wenzhou Medical University | Wenzhou | 325027 | China |
| Central Theater General Hospital of the Chinese People's Liberation Army | Wuhan | China |
| Wuxi No.2 People's Hospital | Wuxi | 214000 | China |
| Xi'an People's Hospital (Xi'an Fourth Hospital) | Xi'an | China |
| Chi De Creteil | Créteil | 94010 | France |
| Hopital de la croix rousse | Lyon | 69317 | France |
| Centre Paradis Monticelli | Marseille | 13008 | France |
| CHU Nantes - Hotel Dieu | Nantes | 44093 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Fondation Rothschild | Paris | 75940 | France |
| Centres Ophtalmologique St Exupéry | Saint-Cyr-sur-Loire | 37540 | France |
| Universitatsklinikum Koln | Cologne | 50937 | Germany |
| Universitätsklinikum Freiburg, Klinik für Augenheilkunde | Freiburg im Breisgau | 79106 | Germany |
| Knappschaftsklinikum Saar GmbH | Sulzbach | 66280 | Germany |
| The University of Hong Kong | Hong Kong | Hong Kong |
| Hong Kong Eye Hospital | Mong Kok | Hong Kong |
| Ospedale Clinicizzato SS Annunziata | Chieti | Abruzzo | 66100 | Italy |
| Policlinico di Bari | Bari | Apulia | 70124 | Italy |
| Ospedale Monaldi - AORN dei Colli | Naples | Campania | 80131 | Italy |
| Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico | Rome | Lazio | 00184 | Italy |
| Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena | Milan | Lombardy | 20100 | Italy |
| A.O. Universitaria S. Maria Della Misericordia Di Udine | Udine | Veneto | 33100 | Italy |
| OFTALMIKA Sp. z o.o | Bydgoszcz | 85-631 | Poland |
| Gabinet Okulistyczny Prof Edward Wylegala | Katowice | 40-594 | Poland |
| Centrum Medyczne UNO-MED | Krakow | 31-070 | Poland |
| Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o. | Lódz | 91-134 | Poland |
| Gabinet Okulistyczny Jerzy Mackiewicz | Lublin | 20-064 | Poland |
| Centrum Diagnostyki i Mikrochirurgii Oka LENS | Olsztyn | 10-424 | Poland |
| National University Hospital | Singapore | 119074 | Singapore |
| Singapore Eye Research Institute | Singapore | 168751 | Singapore |
| Asia Pacific Eye Centre | Singapore | 258500 | Singapore |
| Tan Tock Seng Hospital | Singapore | 308433 | Singapore |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Kim's Eye Hospital | Seoul | 07301 | South Korea |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Complejo Hospitalario Universitario de Santiago. | Santiago de Compostela | LA Coruna | 15706 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital de la Arruzafa. Servicio de Oftalmologia | Córdoba | 14012 | Spain |
| Oftalvist | Madrid | 28006 | Spain |
| Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| National Taiwan University Hospital | Zhongzheng Dist. | 10002 | Taiwan |
| ID | Term |
|---|---|
| C000723200 | faricimab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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