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Neovascular Age-related Macular DegenerationPhase 3NCT05569148

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

A Phase 3 study testing Faricimab PFS Configuration in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Hoffmann-La Roche at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Faricimab PFS Configuration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesUnited States
Study dates
17 Oct 2022to 10 Nov 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona, 85206

  • Associated Retina Consultants

    Phoenix, Arizona, 85020

  • Retinal Consultants of Arizona

    Phoenix, Arizona, 85053

Other trials in United States

About this study

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

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.

Being tested
Faricimab PFS Configuration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Faricimab PFS ConfigurationCombination product

    Also called VABYSMO™, RO6867461, RG7716

    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.

Study groups in NCT05569148
Study groupRoleWhat they receive
Faricimab PFS ConfigurationExperimentalNot described
Receives: Combination Product: Faricimab PFS Configuration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration

    Thirteen healthcare providers (HCP; seven retina specialists and six assistants) across three sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or retina specialist with assistant, as per local procedure) were asked to perform all preparation and administration steps in view of the HF observers. Critical tasks were observed by the HF observers who documented HCP performance using an assessment checklist. A successful task completion for each critical task was defined as normal use without use error, and the percentages of successful completions are calculated out of the total 35 PFS IVT injections administered.

    Measured: Day 1

  2. Percentage of Injection Procedures With Use Errors on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration

    Thirteen healthcare providers (HCP) across 3 sites participated in the study, and they worked mostly in pairs to administer a single intravitreal (IVT) injection of 6-mg faricimab to each of the 35 patients using the prefilled syringe (PFS). For each IVT injection, two Human Factors (HF) observers were positioned such that they could clearly observe the entire preparation and administration process. Each HCP team (i.e., retina specialist alone or retina specialist with assistant, as per local procedure) were asked to perform all preparation and administration steps in view of the HF observers. Critical tasks were observed by the HF observers who documented HCP performance using an assessment checklist. A use error was defined as user action or lack of user action while using the medical device that leads to a different result than that intended by the manufacturer or expected by the user. The percentages of use errors are calculated out of the total 35 PFS IVT injections administered.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2022
  2. Study start17 Oct 2022
  3. Primary completion10 Nov 2022
  4. Study completion10 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05569148
Sponsor's protocol ID
GR43742
Status last verified
Sep 2023
First submitted
4 Oct 2022
Last updated
10 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).

Publications

  • Barakat MR, Kwong HM Jr, Marcon G, O'Leary OE, Paris LP, Schneider P, Tang Y, Graff JM. Human Factors Studies to Assess the Usability of the Faricimab Prefilled Syringe. Clin Ophthalmol. 2025 Feb 6;19:395-406. doi: 10.2147/OPTH.S503060. eCollection 2025.

    PubMed 39931677

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Faricimab PFS Configuration in people with Neovascular Age-related Macular Degeneration and Diabetic Macular Edema, run by Hoffmann-La Roche at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Injection Procedures With Successful Completions on Critical Tasks Performed by Healthcare Providers in the Use of the Faricimab Prefilled Syringe Configuration (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05569148, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.

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