Clinical trial NCT06176352: A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-12-19
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12
timeFrame: Baseline and Average of Weeks 4, 8, and 12
Secondary outcomes:
measure: Change from Baseline in BCVA Over Time
timeFrame: From Baseline through Week 48
measure: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Averaged Over Weeks 4, 8, and 12
timeFrame: Baseline and Average of Weeks 4, 8, and 12
measure: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time
timeFrame: From Baseline through Week 48
measure: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
timeFrame: From Baseline through Week 48
measure: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline or Achieving a BCVA of ≥84 Letters Over Time
timeFrame: From Baseline through Week 48
measure: Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
timeFrame: From Baseline through Week 48
measure: Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
timeFrame: From Baseline through Week 48
measure: Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48
timeFrame: From Baseline to Weeks 12, 24, and 48
measure: Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48
timeFrame: From Baseline to Weeks 12, 24, and 48
measure: Change from Baseline in Central Subfield Thickness (CST) of the Study Eye Averaged Over Weeks 4, 8, and 12
timeFrame: Baseline and Average of Weeks 4, 8, and 12
measure: Change from Baseline in CST of the Study Eye Over Time
timeFrame: From Baseline through Week 48
measure: Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48
timeFrame: Baseline, Weeks 12 and 48
measure: Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48
timeFrame: Baseline, Weeks 12 and 48
measure: Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48
timeFrame: Weeks 12 and 48
measure: Incidence and Severity of Ocular Adverse Events
timeFrame: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
measure: Incidence and Severity of Non-Ocular Adverse Events
timeFrame: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
measure: Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
timeFrame: At Baseline and from first dose until end of study (up to 48 weeks)
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: South West Retina
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Eye Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina Clinic and Day Surgery
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre For Eye Research Australia
state: Victoria
city: Rowville
country: Australia
facility: Retina Specialists Victoria
state: Victoria
city: Beijing City
country: China
facility: Peking Union Medical College Hospital
city: Beijing City
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Beijing Hospital of Ministry of Health
city: Beijing
country: China
facility: Beijing Tong Ren Hospital, Capital Medical University
city: Changchun
country: China
facility: The Second Hospital of Jilin University
city: Guangzhou City
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
city: Qingdao
country: China
facility: Qingdao Eye Hospital of Shandong First Medical University
city: Shanghai City
country: China
facility: Eye & ENT Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
city: Shenyang
country: China
facility: First Hospital of China Medical University
city: Taiyuan City
country: China
facility: Shanxi Eye Hospital
city: Tianjin City
country: China
facility: Tianjin Medical University Eye Hospital
city: Wenzhou City
country: China
facility: Eye Hospital, Wenzhou Medical University
city: Wuhan
country: China
facility: Central Theater General Hospital of the Chinese People's Liberation Army
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
city: XI An
country: China
facility: Xi'an People's Hospital (Xi'an Fourth Hospital)
city: Creteil
country: France
facility: Chi De Creteil
city: Ecully
country: France
facility: Pole Vision Val d'Ouest
city: Lyon cedex
country: France
facility: Hopital de la croix rousse
city: Marseille
country: France
facility: Centre Paradis Monticelli
city: Nantes
country: France
facility: CHU Nantes - Hôtel Dieu
city: Paris Cedex 19
country: France
facility: Fondation Rothschild
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: CHNO des Quinze Vingts
city: St Cyr Sur Loire
country: France
facility: Centres Ophtalmologique St Exupéry
city: Strasbourg
country: France
facility: Centre Ophtalmologique Maison-Rouge
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen Georg-August-Universität
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Sulzbach
country: Germany
facility: Knappschaftsklinikum Saar GmbH
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
city: Mongkok
country: Hong Kong
facility: Hong Kong Eye Hospital
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS Annunziata
state: Abruzzo
city: Napoli
country: Italy
facility: Ospedale Monaldi - AORN dei Colli
state: Campania
city: Roma
country: Italy
facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
state: Lazio
city: Milano
country: Italy
facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena
state: Lombardia
city: Bari
country: Italy
facility: Policlinico di Bari
state: Puglia
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine
state: Veneto
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: ?ód?
country: Poland
facility: Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.
city: Bydgoszcz
country: Poland
facility: OFTALMIKA Sp. z o.o
city: Gliwice
country: Poland
facility: Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
city: Katowice
country: Poland
facility: Gabinet Okulistyczny Prof Edward Wylegala
city: Krakow
country: Poland
facility: Centrum Medyczne UNO-MED
city: Lublin
country: Poland
facility: Gabinet Okulistyczny Jerzy Mackiewicz
city: Olsztyn
country: Poland
facility: Centrum Diagnostyki i Mikrochirurgii Oka LENS
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
city: Singapore
country: Singapore
facility: Asia Pacific Eye Centre
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: L' Hospitalet DE Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago.
state: LA Coruna
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Instituto de microcirugia ocular
city: Cordoba
country: Spain
facility: Hospital de la Arruzafa. Servicio de Oftalmologia
city: Madrid
country: Spain
facility: Oftalvist
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Zhongzheng Dist.
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: