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

Phase 3

Recruiting

• Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia
• Interventions: Drug: Faricimab; Drug: Ranibizumab; Procedure: Sham Procedure

• Registration Number: NCT06176352
• Lead Sponsor: Hoffmann-La Roche

Brief 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). 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-19
• Study Start: 2024-03-06
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-08-12
• Study Completion: 2026-04-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Faricimab	Sham Procedure	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 A: Faricimab	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.
Arm B: Ranibizumab	Sham Procedure	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.
Arm B: Ranibizumab	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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 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
Change from Baseline in CST of the Study Eye Over Time	From Baseline through Week 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)
Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48	Weeks 12 and 48
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)

Trial Locations

Locations (76)

Chi De Creteil; 🇫🇷 Creteil, France

Pole Vision Val d'Ouest; 🇫🇷 Ecully, France

Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.; 🇵🇱 ?ód?, Poland

South West Retina; 🇦🇺 Liverpool, New South Wales, 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, Australia

Centre For Eye Research Australia; 🇦🇺 East Melbourne, Victoria, Australia

Retina Specialists Victoria; 🇦🇺 Rowville, Victoria, Australia

Peking Union Medical College Hospital; 🇨🇳 Beijing City, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing City, China

Beijing Hospital of Ministry of Health; 🇨🇳 Beijing, China

Beijing Tong Ren Hospital, Capital Medical University; 🇨🇳 Beijing, 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

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai City, China

Shanghai First People's Hospital; 🇨🇳 Shanghai, 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, China

Xi'an People's Hospital (Xi'an Fourth Hospital); 🇨🇳 XI An, China

Hopital de la croix rousse; 🇫🇷 Lyon cedex, France

Centre Paradis Monticelli; 🇫🇷 Marseille, France

CHU Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

Fondation Rothschild; 🇫🇷 Paris Cedex 19, France

Hopital Lariboisiere; 🇫🇷 Paris, France

CHNO des Quinze Vingts; 🇫🇷 Paris, France

Centres Ophtalmologique St Exupéry; 🇫🇷 St Cyr Sur Loire, France

Centre Ophtalmologique Maison-Rouge; 🇫🇷 Strasbourg, France

Universitätsklinikum Freiburg, Klinik für Augenheilkunde; 🇩🇪 Freiburg, Germany

Universitätsmedizin Göttingen Georg-August-Universität; 🇩🇪 Göttingen, Germany

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Klinikum rechts der Isar der TU München; 🇩🇪 München, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Knappschaftsklinikum Saar GmbH; 🇩🇪 Sulzbach, Germany

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong

Hong Kong Eye Hospital; 🇭🇰 Mongkok, Hong Kong

Ospedale Clinicizzato SS Annunziata; 🇮🇹 Chieti, Abruzzo, Italy

Ospedale Monaldi - AORN dei Colli; 🇮🇹 Napoli, Campania, Italy

Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico; 🇮🇹 Roma, Lazio, Italy

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena; 🇮🇹 Milano, Lombardia, Italy

Policlinico di Bari; 🇮🇹 Bari, Puglia, Italy

A.O. Universitaria S. Maria Della Misericordia Di Udine; 🇮🇹 Udine, Veneto, Italy

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, 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

OFTALMIKA Sp. z o.o; 🇵🇱 Bydgoszcz, Poland

Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA; 🇵🇱 Gliwice, 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, Poland

National University Hospital; 🇸🇬 Singapore, Singapore

Singapore Eye Research Institute; 🇸🇬 Singapore, Singapore

Asia Pacific Eye Centre; 🇸🇬 Singapore, Singapore

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Hospital Universitario de Bellvitge; 🇪🇸 L' Hospitalet DE Llobregat, Barcelona, Spain

Complejo Hospitalario Universitario de Santiago.; 🇪🇸 Santiago de Compostela, LA Coruna, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Instituto de microcirugia ocular; 🇪🇸 Barcelona, Spain

Hospital de la Arruzafa. Servicio de Oftalmologia; 🇪🇸 Cordoba, Spain

Oftalvist; 🇪🇸 Madrid, Spain

Far Eastern Memorial Hospital; 🇨🇳 New Taipei City, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Zhongzheng Dist., Taiwan