Neovascular Age-related Macular DegenerationNCT06124677
Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments
An observational study of Neovascular Age-related Macular Degeneration, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Faricimab
- Type of treatment
- Injection or infusion
- How many people
- 46 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with neovascular age-related macular degeneration (AMD)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Being tested
- Faricimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FaricimabDrug
Also called Vabysmo (6 mg, 0.05 ml)
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients who received intravitreal faricimab injections between May and September, in 2023. and conform the inclusion/exclusion criteria. Receives: Drug: Faricimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (5)
Durability of a single injection in cases of favorable treatment response without residual fluid
Time of reappearance of the fluid
Measured: Up to 16 weeks
Differences in patient characteristics between individuals responding and not responding to faricimab
Measured: 4 weeks
Changes in visual acuity after the treatment switch
Measured: 4 weeks
Changes in central retinal thickness after the treatment switch
Measured on optical coherence tomography (OCT) scans
Measured: 4 weeks
Changes in pigment epithelium detachment (PED) height after the treatment switch
Measured on optical coherence tomography (OCT) scans
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Nov 2023
- Primary completion15 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miklos Schneider MD, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Miklos Schneider, MD, PhD, Principal investigator, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124677
- Sponsor's protocol ID
- VAB1SHOT
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38416237
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06124677
- Acronym / sponsor ID
- VAB1SHOT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: FaricimabPatients who received intravitreal faricimab injections between May and September, in 2023. and conform the inclusion/exclusion criteria. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with neovascular age-related macular degeneration (AMD)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FaricimabAlso: Vabysmo (6 mg, 0.05 ml)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. | Drug | Patients |
Primary outcome
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
5 secondary outcomes
Durability of a single injection in cases of favorable treatment response without residual fluid
Time frame: Up to 16 weeks
Differences in patient characteristics between individuals responding and not responding to faricimab
Time frame: 4 weeks
Changes in visual acuity after the treatment switch
Time frame: 4 weeks
Changes in central retinal thickness after the treatment switch
Time frame: 4 weeks
Changes in pigment epithelium detachment (PED) height after the treatment switch
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Derived from this study: PubMed 38416237Schneider 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miklos Schneider, MD, PhD principal investigator
Glostrup University Hospital, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients responding to the treatment switch (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06124677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.