Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments

NCT06124677 | Completed FDA Drug

• 1 other identifier: VAB1SHOT
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective single-center chat review is to establish the efficacy and safety of a single dose of intravitreal faricimab (Vabysmo®) injection in patients with neovascular age-related macular degeneration (AMD), who were previously treated with aflibercept (Eylea®) and had persisting intraretinal or subretinal fluid despite frequent treatments.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Proportion of patients responding to the treatment switch

  Defined as reduction or disappearance of the intra- or subretinal fluid at 4 weeks following a single injection of faricimab

  4 weeks

Secondary Outcomes (5)

• Durability of a single injection in cases of favorable treatment response without residual fluid

  Up to 16 weeks

• Differences in patient characteristics between individuals responding and not responding to faricimab

  4 weeks

• Changes in visual acuity after the treatment switch

  4 weeks

• Changes in central retinal thickness after the treatment switch

  4 weeks

• Changes in pigment epithelium detachment (PED) height after the treatment switch

  4 weeks

Other Outcomes (1)

• Frequency of ocular and systemic adverse events

  4 weeks

Study Arms (1)

Patients

Patients who received intravitreal faricimab injections between May and September, in 2023. and conform the inclusion/exclusion criteria.

Drug: Faricimab

Interventions

Faricimab DRUG

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.

Also known as: Vabysmo (6 mg, 0.05 ml)

Patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with neovascular age-related macular degeneration (AMD)

You may qualify if:

• Presence of neovascular age-related macular degeneration (AMD) in the study eye
• \>50 years of age
• Previous intravitreal anti-VEGF treatment with aflibercept (Eylea®) or with aflibercept and ranibizumab (Lucentis®) in the study eye
• Minimum of 6 monthly aflibercept injections
• Persisting intraretinal or subretinal fluid or both, despite at least 3 consecutive monthly aflibercept injections in the study eye before switching to faricimab

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Miklos Schneider

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• Schneider M, Bjerager J, Hodzic-Hadzibegovic D, Klefter ON, Subhi Y, Hajari J. Short-term outcomes of treatment switch to faricimab in patients with aflibercept-resistant neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2024 Jul;262(7):2153-2162. doi: 10.1007/s00417-024-06421-0. Epub 2024 Feb 28.

  PMID: 38416237 DERIVED

MeSH Terms

Interventions

faricimab

Study Officials

• Miklos Schneider, MD, PhD

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Specialist

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 9, 2023
• Study Start: November 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 1, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

DK (1)