Neovascular Age-related Macular DegenerationPhase 4FANNCT05941715
Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration
A Phase 4 study testing Aflibercept 40 MG/ML and Faricimab 120 MG/ML in people with Neovascular Age-related Macular Degeneration, run by Medical University of Graz at 1 site in Austria.
Trial summary
Study purpose: To evaluate if previously high-frequent (3-5 weekly) aflibercept treated neovascular age-related macular degeneration (nAMD) can be extended in their treatment interval when switched to faricimab. 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?
- Aflibercept 40 MG/ML and Faricimab 120 MG/ML
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 4 Jul 2023to 26 Feb 2025
- Phase
- Phase 4
- 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
Ocular inclusion criteria:
- MNV due to AMD (nAMD)
- BVCA between and including 19 and 75 letters (Snellen equivalent approximately 20/400 to 20/32)
- ≥ 7 previous intravitreal injections with anti-VEGF
- the last ≥ 4 consecutive intravitreal injections with aflibercept
- the last aflibercept injections within the last 35 days
- interval between the last 2 aflibercept injections ≤ 35 days
Ocular exclusion criteria:
- MNV due to other causes than nAMD
- polypoidal choroidal neovascularization
- retinal pigment epithelial rip/tear
- subretinal hemorrhage of > 50% of the lesion, involving the fovea
- any macular pathology other than AMD causing structural changes of the macula and thereby affecting vision
- any active intra-/periocular infection/inflammation of the study eye
- uncontrolled glaucoma under medication (IOP >25mmHg)
- cataract surgery of the study eye within the last 3 months
- previous intraocular surgery of the study eye other than cataract surgery or intravitreal injections with anti-VEGF (e.g. vitrectomy, corneal transplant, glaucoma surgery)
- any previous laser therapy of the study eye other than Yag (yttrium aluminium garnet) laser capsulotomy (e.g. panretinal photocoagulation, verteporfin photodynamic therapy)
- refractive error of more than -6 diopters myopia
- vitreous hemorrhage
- retinal detachment
General exclusion criteria
- use of long-term systemic corticosteroids within the last 3 months
- uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg)
- pregnancy (pre-menopausal women MUST take a pregnancy test at time of initiation)
- breast-feeding
- myocardial infarction or stroke within the last six months
- concomitant participation in another clinical study with investigational medicinal products
- a known allergy or hypersensitivity towards eye drops needed for the examinations planned during the study, and/or the intravitreal procedure.
- a known allergy or hypersensitivity against fluorescein / indocyanine green used during angiography
- a known allergy or hypersensitivity towards any of the components of the study drug
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Ophthalmolgy, Medical University Graz
Graz, Styria, 8036
About this study
Official title: Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration: a Monocenter, Randomized, Double-masked Comparator-controlled Study (FAN)
Study purpose: To evaluate if previously high-frequent (3-5 weekly) aflibercept treated neovascular age-related macular degeneration (nAMD) can be extended in their treatment interval when switched to faricimab.
Primary objective: To assess the efficacy of faricimab compared to aflibercept in terms of durability at 32 weeks by extending treatment interval in previous high-frequent aflibercept treated nAMD.
Read the detailed description
There is a subgroup of nAMD patient requiring monthly interventions, when applying as needed and treat-and-extend treatment strategies. A burden for both patient/caregivers and health care systems. More durable treatment options are needed to increase the quality of life for these nAMD patients, as well as to make human resources available for the growing elderly AMD population requiring treatment.
The FAN study is a randomized, double-masked, 2-arm (comparator-controlled), phase-IV, monocenter study with a primary endpoint at 32 weeks. The study is conducted into 2 parts. Patients will receive either aflibercept or faricimab via treat-and-extend principle until the primary endpoint (part 1). As mentioned, the main objective is to assess the durability of both drugs in this particular subgroup of nAMD patients. In part 2 of the study, starting at or after 32 weeks, all patients will receive faricimab via treat-and-extend until the end of the study (56 weeks).
- Being tested
- Aflibercept 40 MG/ML, Faricimab 120 MG/ML
- Keywords
- aflibercept, faricimab, treat and extend, nAMD, AMD, neovascular age-related macular degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept 40 MG/MLDrug
Also called Eylea®
treat-and-extend
Faricimab 120 MG/MLDrug
Also called Vabysmo®
treat-and-extend
| Study group | Role | What they receive |
|---|---|---|
| group A: aflibercept first (part 1), switch to faricimab (part 2) | Active comparator | Aflibercept 2.0mg/0.05ml intravitreal will be administered from baseline through to the first visit at or after 32 weeks in a treat-and-extend regime.
At the first visit at or after 32 weeks, faricimab 6.0mg/0.05ml intravitreal will be administered in a treat-and-extend regime through to the last visit before 56 weeks. Receives: Drug: Aflibercept 40 MG/ML; Drug: Faricimab 120 MG/ML |
| group B: faricimab monotherapy | Experimental | Faricimab 6.0mg/0.05ml intravitreal will be administered from baseline through to the last visit before 56 weeks in a treat-and-extend regime. Receives: Drug: Faricimab 120 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Measured: at 32 weeks
Secondary outcomes (4)
Proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 weeks and (≥ 12weeks)
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Measured: at 32 weeks and 56 weeks
Maximum extended treatment interval without retinal (intra- and subretinal) fluid
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Measured: at 32 weeks and 56 weeks
Number of injections received
Measured: during 32 weeks and 1 year
Proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval)
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
Measured: at 32 weeks and 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start4 Jul 2023
- Primary completion25 Sep 2024
- Study completion26 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Wedrich, MD, Principal investigator, Department of Ophthalmology, Medical University Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941715
- Sponsor's protocol ID
- 35-200 ex 22/23
- Other IDs
- 2023-000037-32, 2023
- Acronym
- FAN
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2023
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration: a Monocenter, Randomized, Double-masked Comparator-controlled Study (FAN)
- ClinicalTrials.gov ID
- NCT05941715
- Acronym / sponsor ID
- FAN / 35-200 ex 22/23
- Keywords
- aflibercept, faricimab, treat and extend, nAMD, AMD, neovascular age-related macular degeneration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 12 Jul 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.
Study purpose: To evaluate if previously high-frequent (3-5 weekly) aflibercept treated neovascular age-related macular degeneration (nAMD) can be extended in their treatment interval when switched to faricimab.
Primary objective: To assess the efficacy of faricimab compared to aflibercept in terms of durability at 32 weeks by extending treatment interval in previous high-frequent aflibercept treated nAMD.
Detailed description
There is a subgroup of nAMD patient requiring monthly interventions, when applying as needed and treat-and-extend treatment strategies. A burden for both patient/caregivers and health care systems. More durable treatment options are needed to increase the quality of life for these nAMD patients, as well as to make human resources available for the growing elderly AMD population requiring treatment.
The FAN study is a randomized, double-masked, 2-arm (comparator-controlled), phase-IV, monocenter study with a primary endpoint at 32 weeks. The study is conducted into 2 parts. Patients will receive either aflibercept or faricimab via treat-and-extend principle until the primary endpoint (part 1). As mentioned, the main objective is to assess the durability of both drugs in this particular subgroup of nAMD patients. In part 2 of the study, starting at or after 32 weeks, all patients will receive faricimab via treat-and-extend until the end of the study (56 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A: aflibercept first (part 1), switch to faricimab (part 2) | Active comparator | Drug: Aflibercept 40 MG/ML, Drug: Faricimab 120 MG/MLAflibercept 2.0mg/0.05ml intravitreal will be administered from baseline through to the first visit at or after 32 weeks in a treat-and-extend regime. At the first visit at or after 32 weeks, faricimab 6.0mg/0.05ml intravitreal will be administered in a treat-and-extend regime through to the last visit before 56 weeks. |
| group B: faricimab monotherapy | Experimental | Drug: Faricimab 120 MG/MLFaricimab 6.0mg/0.05ml intravitreal will be administered from baseline through to the last visit before 56 weeks in a treat-and-extend regime. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Aflibercept 40 MG/MLAlso: Eylea®treat-and-extend | Drug | group A: aflibercept first (part 1), switch to faricimab (part 2) |
| Faricimab 120 MG/MLAlso: Vabysmo®treat-and-extend | Drug | group A: aflibercept first (part 1), switch to faricimab (part 2), group B: faricimab monotherapy |
Primary outcome
Proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
Time frame: at 32 weeks
Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.
4 secondary outcomes
Proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 weeks and (≥ 12weeks)
Time frame: at 32 weeks and 56 weeks
Maximum extended treatment interval without retinal (intra- and subretinal) fluid
Time frame: at 32 weeks and 56 weeks
Number of injections received
Time frame: during 32 weeks and 1 year
Proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval)
Time frame: at 32 weeks and 56 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 6 Jun 2025.
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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.
Andreas Wedrich, MD principal investigator
Department of Ophthalmology, Medical University Graz
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 Aflibercept 40 MG/ML and Faricimab 120 MG/ML in people with Neovascular Age-related Macular Degeneration, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Jun 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 Austria. 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?
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 eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate) (time frame: at 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2025.