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Faricimab for high-frequent Aflibercept treated Neovascular age-related macular degeneration: a monocenter, randomized, double-masked comparator-controlled study (FAN study)

Status
Completed
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515377-10-00
Enrollment
70
Registered
2024-11-18
Start date
2023-06-12
Completion date
2025-02-26
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular age-related macular degeneration

Brief summary

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)

Detailed description

proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8 and ≥ 10 weeks at 32 weeks, maximum extended treatment interval without retinal (intra- and subretinal) fluid at 32 weeks, number of injections received during 32 weeks, proportion of eyes with maximum extended interval without retinal (intra-and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 and ≥12weeks at 56 weeks, proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval) at 56 weeks, maximum extended treatment interval without retinal (intra- and subretinal) fluid at 56 weeks, number of injections received during 1 year, mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 24 and 32 weeks, mean averaged EDTRS letter score between 24 and 32 weeks, mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 48 and 56 weeks, mean averaged EDTRS letter score between 48 and 56 weeks, proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks, proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks, proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks, proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks, mean change in low-luminance BCVA from baseline over time, mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 24 and 32 weeks, mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 48 and 56 weeks, proportion of eyes with no intraretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks, proportion of eyes with no subretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks, proportion of eyes with no retinal (intra- and subretinal) fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks, retinal nerve fiber analysis over time, incidence and severity of ocular/non-ocular adverse events, initial concentration of plasma VEGF-A, Ang-2, mean change in concentration of plasma VEGF-A, Ang-2 over time, change in NEI VFO-25 total score over time

Interventions

Sponsors

Medical University Of Graz, Medical University Of Graz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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)

Secondary

MeasureTime frame
proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8 and ≥ 10 weeks at 32 weeks, maximum extended treatment interval without retinal (intra- and subretinal) fluid at 32 weeks, number of injections received during 32 weeks, proportion of eyes with maximum extended interval without retinal (intra-and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 and ≥12weeks at 56 weeks, proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval) at 56 weeks, maximum extended treatment interval without retinal (intra- and subretinal) fluid at 56 weeks, number of injections received during 1 year, mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 24 and 32 weeks, mean averaged EDTRS letter score between 24 and 32 weeks, mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 48 and 56 weeks, mean averaged EDTRS letter score between 48 and 56 weeks,

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026