Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments
NCT ID: NCT06124677
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
46 participants
OBSERVATIONAL
2023-11-01
2023-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients
Patients who received intravitreal faricimab injections between May and September, in 2023. and conform the inclusion/exclusion criteria.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>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
* 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
50 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Miklos Schneider MD, PhD
Staff Specialist
Principal Investigators
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Miklos Schneider, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet Glostrup
Locations
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Miklos Schneider
Glostrup Municipality, , Denmark
Countries
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References
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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.
Other Identifiers
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VAB1SHOT
Identifier Type: -
Identifier Source: org_study_id