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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05569148
• Collaborator: (none)
• Enrollment: 35
• Locations: 3
• Arm: 1
• Actual Duration (Days): 24
• Patients Per Site: 11.7
• Patients Per Site Per Month: 14.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration; Diabetic Macular Edema	Combination Product: Faricimab PFS Configuration	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase IIIb, Open-Label, Single-Arm Study in Patients With Neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety of the 6-mg Faricimab Prefilled Syringe
• Actual Study Start Date: Oct 17, 2022
• Actual Primary Completion Date: Nov 10, 2022
• Actual Study Completion Date: Nov 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Faricimab PFS Configuration	Combination Product: Faricimab PFS Configuration; 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.; Other Names: VABYSMO™ RO6867461 RG7716

Outcome Measures

Primary Outcome Measures

1. Percentage of Successful Task Completions by Healthcare Providers on Critical Tasks for Use of the Faricimab Prefilled Syringe Configuration [Day 1]

2. Percentage of Use Errors by Healthcare Providers on Critical Tasks for Use of the Faricimab Prefilled Syringe Configuration [Day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barnet Dulaney Perkins Eye Center	Mesa	Arizona	United States	85206
2	Associated Retina Consultants	Phoenix	Arizona	United States	85020
3	Retinal Consultants of Arizona	Phoenix	Arizona	United States	85053

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT05569148
• Other Study ID Numbers: GR43742
• First Posted: Oct 6, 2022
• Last Update Posted: Jan 4, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Macular Edema; Wet Macular Degeneration; Edema

Study Results

No Results Posted as of Jan 4, 2023