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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-000037-32 | EudraCT Number |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept 40 MG/ML | Drug | treat-and-extend |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in ETDRS letter score | Best Corrected Visual Acuity (BCVA) is measured via Early Treatment Diabetic Retinopathy Severity (ETDRS) charts. The ETDRS letter score ranges from 0 to 100 (best score). | from baseline to an averaged EDTRS letter score between 24-32 weeks and between 48-56 weeks |
| Mean averaged ETDRS letter score |
Ocular inclusion criteria:
Ocular exclusion criteria:
General exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Wedrich, MD | Department of Ophthalmology, Medical University Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmolgy, Medical University Graz | Graz | Styria | 8036 | Austria |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
| C000723200 | faricimab |
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| Faricimab 120 MG/ML | Drug | treat-and-extend |
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| 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. | at 32 weeks and 56 weeks |
| Number of injections received | 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. | at 32 weeks and 56 weeks |
Best Corrected Visual Acuity (BCVA) is measured via Early Treatment Diabetic Retinopathy Severity (ETDRS) charts. The ETDRS letter score ranges from 0 to 100 (best score). |
| between 24-32 weeks and between 48-56 weeks |
| Proportion of eyes gaining ≥ 5 EDTRS letters | from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks |
| Proportion of eyes loosing ≥5 EDTRS letters | from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks |
| Mean change in low-luminance Best Corrected Visual Acuity (BCVA) | from baseline to last visit at or before 32 weeks and last visit at or before 56 weeks |
| Mean change in central subfield thickness (CST) | CST is measured using optical coherence tomography (OCT). | from baseline to an averaged CST between 24-32 weeks and between 48-56 weeks |
| Proportion of eyes with no intraretinal fluid | Intraretinal fluid is assessed via optical coherence tomography (OCT). | at baseline, last visit at or before 32 weeks and at or before 56 weeks |
| Proportion of eyes with no subretinal fluid | Subretinal fluid is assessed via optical coherence tomography (OCT). | at baseline, last visit at or before 32 weeks and at or before 56 weeks |
| Proportion of eyes with no intra- and subretinal fluid | Intra- and subretinal fluid is assessed via optical coherence tomography (OCT). | at baseline, last visit at or before 32 weeks and at or before 56 weeks |
| Retinal nerve fiber layer (RNFL) thickness | RNFL thickness is assessed via optical coherence tomography (OCT). | at baseline, last visit at or before 32 weeks and last visit at or before 56 weeks |
| Concentration of plasma vascular endothelial growth factor A (VEGF-A) and Angiopoietin-2 (Ang-2) | Plasma VEGF-A and Ang-2 is determined using a validated enzyme-linked immunosorbent assay (ELISA). | at baseline, one week after baseline, four weeks after baseline and last visit at or before 32 weeks |
| Patient-reported vision-related functioning and quality of life | Patient-reported vision-related functioning and quality of life is assessed via National Eye Institute Visual Function Questionnaire (VFQ-25). VFQ-25 score ranges from 0 to 100 (highest score). | at screening, last visit at or before 32 weeks and last visit at or before 56 weeks |
| Presence of safety outcomes | Rates of adverse events (AE's) and serious adverse events (SAE's) are given. | from baseline through to week 56 |