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

NCT06176352

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia

Interventions: Faricimab, Ranibizumab, Sham Procedure

Countries: Australia, China, France, Germany, Hong Kong, Italy, Poland, Singapore

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (63)
  • Strathfield, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • East Melbourne, Victoria, Australia
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Guangzhou, China
  • Harbin, China
  • Qingdao, China
  • Shanghai, China
  • Shanghai, China
  • Shenyang, China
  • Taiyuan, China
  • Tianjin, China
  • Wenzhou, China
  • Wuhan, China
  • Wuxi, China
  • Xi'an, China
  • Créteil, France
  • Lyon, France
  • Marseille, France
  • Nantes, France
  • Paris, France
  • Paris, France
  • Saint-Cyr-sur-Loire, France
  • Cologne, Germany
  • Freiburg im Breisgau, Germany
  • + 33 more on CT.gov