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OpenTrials
Completed

NCT Number: NCT06124677

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Miklos Schneider

Glostrup Municipality, 2600, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

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.

Other names: Vabysmo (6 mg, 0.05 ml)

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: Up to 16 weeks

    Time of reappearance of the fluid

  2. Differences in patient characteristics between individuals responding and not responding to faricimab

    Time frame: 4 weeks

  3. Changes in visual acuity after the treatment switch

    Time frame: 4 weeks

  4. Changes in central retinal thickness after the treatment switch

    Time frame: 4 weeks

    Measured on optical coherence tomography (OCT) scans

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

    Time frame: 4 weeks

    Measured on optical coherence tomography (OCT) scans

Other outcomes

  1. Frequency of ocular and systemic adverse events

    Time frame: 4 weeks

    As safety endpoint

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Anatomical and Visual Outcomes Following a Single Injection of Intravitreal Faricimab in Patients With Neovascular Age-related Macular Degeneration and Persisting Fluid Despite Frequent Aflibercept Treatments

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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