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Evaluating Faricimab for Eye Condition Related to Myopia

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

Phase 3 Interventional Hoffmann-La Roche · NCT06176352

This study is testing if a new eye treatment called faricimab can help people with vision problems caused by myopia just as well as an existing treatment called ranibizumab.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsfaricimab, ranibizumab
Locations76 sites (Liverpool, New South Wales and 75 other locations)
Trial IDNCT06176352 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial is designed to assess the efficacy and safety of faricimab in patients suffering from choroidal neovascularization (CNV) due to pathologic myopia. The study involves a multicenter, randomized, double-masked, active comparator-controlled approach, comparing 6.0 mg of faricimab to 0.5 mg of ranibizumab. Participants will receive treatment based on a pro-re-nata (PRN) dosing regimen following an initial active treatment on Day 1. The trial aims to determine if faricimab is non-inferior to ranibizumab in treating this condition.

Who should consider this trial

Good fit: Ideal candidates include treatment-naïve patients with active myopic CNV and specific visual acuity criteria.

Not a fit: Patients with previous treatments for choroidal neovascularization or those without active leakage from CNV may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with myopic choroidal neovascularization.

How similar studies have performed: Other studies have shown success with similar approaches in treating choroidal neovascularization, indicating potential for this trial's success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Liverpool, New South Wales and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Choroidal Neovascularization Secondary to Pathologic Myopia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.