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OpenTrials
Completed

NCT Number: NCT06231121

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

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.

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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
  • 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

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

    Time frame: 4 weeks

  2. Changes in central retinal thickness after the treatment switch

    Time frame: 4 weeks

    Measured on optical coherence tomography (OCT) scans

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

    Time frame: 4 weeks

    Measured on optical coherence tomography (OCT) scans

  4. Changes in best-corrected visual acuity after the treatment switch

    Time frame: 4 weeks

Other outcomes

  1. Frequency of ocular and systemic adverse events

    Time frame: 4 weeks

    Safety endpoint

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 30, 2024
Registry last updated
Jan 30, 2024

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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