A Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the Faricimab Prefilled Syringe

Last updated: September 12, 2023
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Macular Degeneration

Diabetic Retinopathy

Diabetic Macular Edema

Treatment

Faricimab PFS Configuration

Clinical Study ID

NCT05569148
GR43742
  • Ages > 18
  • All Genders

Study 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

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 fromheterosexual intercourse) or use contraception, and agree to refrain from donatingeggs, as defined in the protocol
  • Confirmed diagnosis of neovascular age-related macular degeneration (nAMD; anysubtype) or diabetic macular edema (DME) in one or both eyes by the study siteinvestigator (only one eye will be selected as the study eye, as determined by theretina specialist) with onset at any time prior to study start
  • Study eye is deemed to be indicated for faricimab intravitreal (IVT) treatment at thediscretion of the retina specialist
  • Hstorical optical coherence tomography (OCT) data available for the study eye within 30 days prior to Day 1

Exclusion

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 consideredprohibited therapy per the protocol
  • Participation in an investigational trial that involves treatment with any drug ordevice (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 toDay 1
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent orknown hypersensitivity to any component of the faricimab prefilled syringe injection,study-related procedure preparations, or any of the anesthetic and antimicrobialpreparations used by a participant during the study
  • History of other disease, metabolic dysfunction, physical examination finding, orclinical laboratory finding giving reasonable suspicion of a condition thatcontraindicates the use of faricimab or renders the patient at high risk for treatmentcomplications in the opinion of the investigator
  • Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic bloodpressure >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 ocularinflammatory reaction (any grading from trace and greater is excluded), includingnon-infectious uveitis or infectious uveitis, or sterile inflammatory reaction afterprevious 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 hemorrhagesafter 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 drugrelease device implantation (approved or investigational) in the study eye at any timeduring 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

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: Faricimab PFS Configuration
Phase: 3
Study Start date:
October 17, 2022
Estimated Completion Date:
November 10, 2022

Connect with a study center

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona 85206
    United States

    Site Not Available

  • Associated Retina Consultants

    Phoenix, Arizona 85020
    United States

    Site Not Available

  • Retinal Consultants of Arizona

    Phoenix, Arizona 85053
    United States

    Site Not Available

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