Macular Degeneration Choroidal NeovascularizationPhase 4Fixed farcimabNCT06742307
Faricimab Quarterly Maintenance for Neovascular Age Related Macular Degeneration
A Phase 4 study testing Faricimab Injection [Vabysmo] in people with Macular Degeneration Choroidal Neovascularization, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration Choroidal Neovascularization
- What is being tested?
- Faricimab Injection [Vabysmo]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 21 Aug 2025to 1 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subjects aged over 50 years, neovascular AMD with foveal involvement, both treatment-naïve and recurrent cases. There were no specific criteria for initial best-corrected visual acuity (BCVA). Only active subfoveal MNV are included, including types 1, 2, and 3.
Who cannot join
- eyes that received any anti-VEGF therapy in the prior six months,
- eyes with other disease entities (e.g., diabetic macula oedema, retinal vein occlusions, central serous chorioretinopathy, myopicmacular neovascularisation),
- concurrent macula laser (except photodynamic therapy) and ocular surgery (e.g., cataract surgery or vitrectomy) in the prior six months and the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, United Chrisitian Hospital
Hong Kong
Suzy Wong, +852 3949 3411, wnp391@ha.org.hk
About this study
Official title: Faricimab Fixed Quarterly Maintenance for Neovascular Age Related Macular Degeneration: A Prospective Case Series
We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre.
Read the detailed description
Age-related macular degeneration (AMD) accounts for 8.7% of all causes of blindness worldwide and is the most common cause of blindness in developed nations. Its prevalence is likely to increase as a consequence of exponential population ageing. Wet, or neovascular, AMD affects 10-15% of AMD patients and is characterised by macular neovascularisation (MNV), where new immature blood vessels grow towards the outer retina, typically from the underlying choroid, result in leakage, fluid accumulation, and haemorrhage. Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A (VEGF-A). Safety and efficacy of intravitreal faricimab were evaluated in phase 3 trials in patients with nAMD. TENAYA and LUCERNE assessed faricimab administered at individualised treatment intervals of up to every 16 weeks compared with aflibercept given every 8 weeks in patients with nAMD.
Different treatment regimens exist, including the pro re nata (PRN) and the treat and extend (T\&E) approaches. Treating macular disease with anti-VEGF has been an enormous burden to ophthalmic services globally. In Hong Kong, anti-VEGF treatment is self-financed, hindering access for the underprivileged. It has been mentioned that most public hospitals in the region are less likely to adopt a T\&E regimen directly after the loading phase but are more inclined towards PRN regimen because of limited manpower and resources .
Generally, three monthly or four-weekly anti-VEGF injections before the introduction of faricimab to the public hospitals in Hospital Authority (HA) in 2023 would be arranged for newly diagnosed patients with nAMD during the initial visit at our institution. Depending on the treatment response, the patient would either be advised to stop injections (PRN regimen), to T\&E regimen by extending the intervals in a stepwise manner, or be put on regular quarterly maintenance injections.
From the full prescribing information supplied by the manufacturer Roche, for nAMD, the recommended dose for Vabysmo® (Faricimab) is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses (at Weeks 0, 4, 8, 12), followed by optical coherence tomography (OCT) and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44 (every 16 weeks); 2) Weeks 24, 36 and 48 (every 12 weeks); or 3) Weeks 20, 28, 36 and 44 (every 8 weeks). Although additional efficacy was not demonstrated in most patients when Vabysmo® was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
As this new drug, faricimab, is becoming available in the hospital authority (HA) in Hong Kong, it is expected to be more extensively given to our patients with nAMD. It is understood from the full prescribing information supplied by Roche that the injection interval can be extended up to 16 weeks. It is vital to have the knowledge whether some less treatment intensive, simple fixed regimen in our locality is comparable to the more intensive dosing suggested by the manufacturer. With the number of injections administered in the territory exponentially rising in recent years due to the ageing population, there is clearly a need to explore better alternatives to the PRN approach and this forms the basis of our study.
- Being tested
- Faricimab Injection [Vabysmo]
- Keywords
- neovascular age related macular degeneration, faricimab
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faricimab Injection [Vabysmo]Drug
A planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. This intervention schedule is not specifically studied in other literature, although similar schedule exist.
| Study group | Role | What they receive |
|---|---|---|
| Faricimab treatment arm | Active comparator | A planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. The intervention faricimab is injected into the eyeball with a 30G needle. Receives: Drug: Faricimab Injection [Vabysmo] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
The primary outcome is the change from baseline in best-corrected visual acuity (BCVA) at week 52.
Measured: 52 weeks
Secondary outcomes (3)
Anatomical success
Anatomical success was defined as no increase in disease activity of the AMD on clinical examination or OCT throughout the study period while remaining on the quarterly dosing schedule, without the need to shorten the treatment interval.
Measured: 52 weeks
Functional success
Functional success was characterised by a loss of fewer than five ETDRS letters, without the need to shorten the treatment interval.
Measured: 52 weeks
Maintenance treatment failure
Maintenance treatment failure was defined as an increase in disease activity during the quarterly dosing maintenance stage, i.e. new macular haemorrhage, neovascularisation, and/or an increase in OCT biomarkers for neovascular activity, and thus a decision for rescue treatment with shorter treatment intervals.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start21 Aug 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Macular Degeneration Choroidal NeovascularizationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients included, once diagnosed with neovascular macular dengeration, will embark on a planned quarterly (every 12-16 weeks) faricimab injection schedule for one year, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. If disease inactivity is not achieved during the maintenance phase, patient's injection interval may be shortened.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wong Ho Daniel Tak, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742307
- Sponsor's protocol ID
- CIRB-2024-169-3
- Acronym
- Fixed farcimab
- Status last verified
- Sep 2025
- First submitted
- 15 Dec 2024
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient number and enrollment status.
Publications
Wong DHT, Li KKW. Fixed Quarterly Dosing of Aflibercept after Loading Doses in Neovascular Age-Related Macular Degeneration in Chinese Eyes. J Clin Med. 2023 Dec 27;13(1):145. doi: 10.3390/jcm13010145.
PubMed 38202151Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.
PubMed 35085502Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.
PubMed 25104651Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.
PubMed 22794258
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faricimab Fixed Quarterly Maintenance for Neovascular Age Related Macular Degeneration: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT06742307
- Acronym / sponsor ID
- Fixed farcimab / CIRB-2024-169-3
- Keywords
- neovascular age related macular degeneration, faricimab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 19 Dec 2024 (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.
We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre.
Detailed description
Age-related macular degeneration (AMD) accounts for 8.7% of all causes of blindness worldwide and is the most common cause of blindness in developed nations. Its prevalence is likely to increase as a consequence of exponential population ageing. Wet, or neovascular, AMD affects 10-15% of AMD patients and is characterised by macular neovascularisation (MNV), where new immature blood vessels grow towards the outer retina, typically from the underlying choroid, result in leakage, fluid accumulation, and haemorrhage. Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A (VEGF-A). Safety and efficacy of intravitreal faricimab were evaluated in phase 3 trials in patients with nAMD. TENAYA and LUCERNE assessed faricimab administered at individualised treatment intervals of up to every 16 weeks compared with aflibercept given every 8 weeks in patients with nAMD.
Different treatment regimens exist, including the pro re nata (PRN) and the treat and extend (T\&E) approaches. Treating macular disease with anti-VEGF has been an enormous burden to ophthalmic services globally. In Hong Kong, anti-VEGF treatment is self-financed, hindering access for the underprivileged. It has been mentioned that most public hospitals in the region are less likely to adopt a T\&E regimen directly after the loading phase but are more inclined towards PRN regimen because of limited manpower and resources .
Generally, three monthly or four-weekly anti-VEGF injections before the introduction of faricimab to the public hospitals in Hospital Authority (HA) in 2023 would be arranged for newly diagnosed patients with nAMD during the initial visit at our institution. Depending on the treatment response, the patient would either be advised to stop injections (PRN regimen), to T\&E regimen by extending the intervals in a stepwise manner, or be put on regular quarterly maintenance injections.
From the full prescribing information supplied by the manufacturer Roche, for nAMD, the recommended dose for Vabysmo® (Faricimab) is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses (at Weeks 0, 4, 8, 12), followed by optical coherence tomography (OCT) and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44 (every 16 weeks); 2) Weeks 24, 36 and 48 (every 12 weeks); or 3) Weeks 20, 28, 36 and 44 (every 8 weeks). Although additional efficacy was not demonstrated in most patients when Vabysmo® was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
As this new drug, faricimab, is becoming available in the hospital authority (HA) in Hong Kong, it is expected to be more extensively given to our patients with nAMD. It is understood from the full prescribing information supplied by Roche that the injection interval can be extended up to 16 weeks. It is vital to have the knowledge whether some less treatment intensive, simple fixed regimen in our locality is comparable to the more intensive dosing suggested by the manufacturer. With the number of injections administered in the territory exponentially rising in recent years due to the ageing population, there is clearly a need to explore better alternatives to the PRN approach and this forms the basis of our study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients included, once diagnosed with neovascular macular dengeration, will embark on a planned quarterly (every 12-16 weeks) faricimab injection schedule for one year, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. If disease inactivity is not achieved during the maintenance phase, patient's injection interval may be shortened.
| Arm | Type | Receives |
|---|---|---|
| Faricimab treatment arm | Active comparator | Drug: Faricimab Injection [Vabysmo]A planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. The intervention faricimab is injected into the eyeball with a 30G needle. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects aged over 50 years, neovascular AMD with foveal involvement, both treatment-naïve and recurrent cases. There were no specific criteria for initial best-corrected visual acuity (BCVA). Only active subfoveal MNV are included, including types 1, 2, and 3.
Key exclusion criteria (3 listed)
- eyes that received any anti-VEGF therapy in the prior six months,
- eyes with other disease entities (e.g., diabetic macula oedema, retinal vein occlusions, central serous chorioretinopathy, myopicmacular neovascularisation),
- concurrent macula laser (except photodynamic therapy) and ocular surgery (e.g., cataract surgery or vitrectomy) in the prior six months and the study period.
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 |
|---|---|---|
| Faricimab Injection [Vabysmo]A planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. This intervention schedule is not specifically studied in other literature, although similar schedule exist. | Drug | Faricimab treatment arm |
Primary outcome
Visual acuity
Time frame: 52 weeks
The primary outcome is the change from baseline in best-corrected visual acuity (BCVA) at week 52.
3 secondary outcomes
Anatomical success
Time frame: 52 weeks
Functional success
Time frame: 52 weeks
Maintenance treatment failure
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Background: PubMed 38202151Wong DHT, Li KKW. Fixed Quarterly Dosing of Aflibercept after Loading Doses in Neovascular Age-Related Macular Degeneration in Chinese Eyes. J Clin Med. 2023 Dec 27;13(1):145. doi: 10.3390/jcm13010145.
- Background: PubMed 35085502Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.
- Background: PubMed 25104651Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.
- Background: PubMed 22794258Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.
- Genentech, Inc, Roche Group. HIGHLIGHTS OF PRESCRIBING INFORMATION.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient number and enrollment status.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Faricimab Injection [Vabysmo] in people with Macular Degeneration Choroidal Neovascularization, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
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 1 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: looking for participants now, as of the sponsor's last update on 1 Oct 2025. 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 Hong Kong. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Ho Tak Wong, FRCOphth (UK) (+852 3949 3411, WHT454@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 52 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 NCT06742307, which also lists 4 linked publications.
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 1 Oct 2025.