Switching to Faricimab in Neovascular Age-related Macular Degeneration Resistant to Both Aflibercept and Ranibizumab

January 21, 2024 updated by: Miklos Schneider MD, PhD, Rigshospitalet, Denmark

Short-term Results With Faricimab After Multiple Sequential Treatment Switches Due to Resistance With Both Aflibercept and Ranibizumab in Neovascular Age-related Macular Degeneration

The goal of this retrospective single-center chart review is to establish the response rate, efficacy and safety of a single dose of intravitreal faricimab injection in real-world patients with aflibercept- and ranibizumab-resistant neovascular age-related macular degeneration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Miklos Schneider

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with neovascular age-related macular degeneration (AMD)

Description

Inclusion criteria

  • Presence of neovascular age-related macular degeneration (AMD) in the study eye
  • Previous treatment with minimum 6 consecutive, monthly aflibercept (Eylea®) injections in the study eye without optimal treatment response, defined as persisting intraretinal fluid or subretinal fluid or both on optical coherence tomography scans
  • Subsequently, a sequential switch to ranibizumab (Lucentis®), with minimum 1 injection, also without optimal response
  • Finally, a sequential treatment switch from ranibizumab to faricimab.

Exclusion criteria

  • Neovascular conditions other than AMD (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye
  • Significant optical media opacities that would result in poor imaging quality on OCT scans in the study eye
  • Intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients who received intravitreal faricimab injections between May and September, in 2023. and conform the inclusion/exclusion criteria.
Drug: Faricimab
The Injections were performed according to local standard protocol, that included the use of 2-3 drops of topical tetracaine anesthesia, use of eye speculum, topical 5% povidone-iodine disinfection, a 30G-needle, injection site 3.5 mm posterior from the limbus marked by calipers in supertemporal or inferotemporal quadrants, a sterile cotton tip tamponade at the site of injection after removal of the needle, and no post-procedure antibiotics.
Other Names:
  • Vabysmo (6 mg, 0.05 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients responding to the treatment switch
Time Frame: 4 weeks
Defined as reduction or disappearance of the intra- or subretinal fluid at 4 weeks following a single injection of faricimab
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in patient characteristics between individuals responding and not responding to faricimab
Time Frame: 4 weeks
4 weeks
Changes in central retinal thickness after the treatment switch
Time Frame: 4 weeks
Measured on optical coherence tomography (OCT) scans
4 weeks
Changes in pigment epithelium detachment (PED) height after the treatment switch
Time Frame: 4 weeks
Measured on optical coherence tomography (OCT) scans
4 weeks
Changes in best-corrected visual acuity after the treatment switch
Time Frame: 4 weeks
4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of ocular and systemic adverse events
Time Frame: 4 weeks
Safety endpoint
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Miklos Schneider, MD, PhD, Rigshospitalet Glostrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

January 15, 2024

Study Completion (Actual)

January 19, 2024

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 21, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MULTISW-VAB1SHOT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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