A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe
Condition: Neovascular Age-related Macular Degeneration; Diabetic Macular Edema
MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration; Edema
Intervention: Faricimab PFS Configuration
Intervention description: Participants will receive a single intravitreal (IVT) injection of the 6-milligram (mg) faricimab dose formulation delivered via prefilled syringe (PFS) with a co-packaged injection filter needle.
Intervention MeSH terms: Faricimab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This Phase IIIb, single-arm, open-label multicenter clinical in-use study in patients with
      neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) is
      designed to assess the ability of the intended users, healthcare providers (HCPs), to follow
      the Instructions for Use to perform an intravitreal (IVT) injection using the 6-milligram
      (mg) faricimab prefilled syringe (PFS) configuration per the intended use. Any adverse events
      occurring during the 7-day study reporting period will be summarized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to comply with clinic visits and study-related procedures

          -  For female patients of childbearing potential: agree to remain abstinent (refrain from
             heterosexual intercourse) or use contraception, and agree to refrain from donating
             eggs, as defined in the protocol

          -  Confirmed diagnosis of neovascular age-related macular degeneration (nAMD; any
             subtype) or diabetic macular edema (DME) in one or both eyes by the study site
             investigator (only one eye will be selected as the study eye, as determined by the
             retina specialist) with onset at any time prior to study start

          -  Study eye is deemed to be indicated for faricimab intravitreal (IVT) treatment at the
             discretion of the retina specialist

          -  Hstorical optical coherence tomography (OCT) data available for the study eye within
             30 days prior to Day 1

        Exclusion Criteria:

          -  Pregnancy or breastfeeding, or intention to become pregnant during the study or within
             3 months after the final dose of faricimab

          -  Requirement on Day 1 for continuous use of any medications and treatments considered
             prohibited therapy per the protocol

          -  Participation in an investigational trial that involves treatment with any drug or
             device (with the exception of vitamins and minerals) within 3 months prior to Day 1

          -  Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to
             Day 1

          -  History of a severe allergic reaction or anaphylactic reaction to a biologic agent or
             known hypersensitivity to any component of the faricimab prefilled syringe injection,
             study-related procedure preparations, or any of the anesthetic and antimicrobial
             preparations used by a participant during the study

          -  History of other disease, metabolic dysfunction, physical examination finding, or
             clinical laboratory finding giving reasonable suspicion of a condition that
             contraindicates the use of faricimab or renders the patient at high risk for treatment
             complications in the opinion of the investigator

          -  Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood
             pressure >100 mmHg while a patient is at rest)

          -  Systemic treatment for suspected or active systemic infection on Day 1

          -  Legally blind in the study eye on Day 1 (legal blindness: Best-corrected visual acuity
             [BCVA] of 20/200 or less)

          -  History of or any current clinically relevant intraocular inflammation or ocular
             inflammatory reaction (any grading from trace and greater is excluded), including
             non-infectious uveitis or infectious uveitis, or sterile inflammatory reaction after
             previous IVT injections with any agent in either eye

          -  Suspected or active ocular or periocular infection in either eye on Day 1

          -  History of or any current indication of excessive bleeding and recurrent hemorrhages,
             including any prior excessive intraocular or subconjunctival bleeding or hemorrhages
             after IVT injection or intraocular procedures in either eye

          -  Uncontrolled glaucoma in the study eye

          -  Treatment with any IVT injection in the study eye within the 27 days prior to Day 1

          -  Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug
             release device implantation (approved or investigational) in the study eye at any time
             during the 3 months prior to Day 1

          -  Treatment with panretinal photocoagulation, laser retinopexy or macular (focal, grid,
             or micropulse) laser in the study eye within one month prior to Day 1