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(22153) Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of Aflibercept 8 mg in Macular Edema Secondary to Retinal Vein Occlusion

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502174-16-00
Acronym
22153
Enrollment
255
Registered
2023-08-22
Start date
2023-09-13
Completion date
2025-05-14
Last updated
2025-06-02

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

Conditions

Macular edema secondary to retinal vein occlusion

Brief summary

Change from baseline in BCVA measured by the ETDRS letter score at Week 36

Detailed description

Number of active injections from baseline to Week 64, Number of active injections from baseline to Week 36, Change from baseline in BCVA measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 44, Change from baseline in BCVA measured by the ETDRS letter score at Week 64, Participant gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64, Participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64, Participant having no intraretinal fluid (IRF) and no sub-retinal fluid (SRF) in the center subfield at Weeks 36 and 64, Change from baseline in CST at Weeks 36 and 64, Change from baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) total score at Weeks 36 and 64, Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 36 and 64, Participant dosed only Q8W through Week 36 in the 8 mg Q8W group, Participant having last treatment interval ≥12 or of 16 weeks at Week 64, Participant having next intended interval ≥12, ≥16 or of 20 weeks at Week 64, Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound and total aflibercept from baseline through Weeks 36 and 64

Interventions

Sponsors

Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in BCVA measured by the ETDRS letter score at Week 36

Secondary

MeasureTime frame
Number of active injections from baseline to Week 64, Number of active injections from baseline to Week 36, Change from baseline in BCVA measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 44, Change from baseline in BCVA measured by the ETDRS letter score at Week 64, Participant gaining at least 15 letters in BCVA from baseline at Weeks 36 and 64, Participant achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Weeks 36 and 64, Participant having no intraretinal fluid (IRF) and no sub-retinal fluid (SRF) in the center subfield at Weeks 36 and 64, Change from baseline in CST at Weeks 36 and 64, Change from baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) total score at Weeks 36 and 64, Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 36 and 64, Participant dosed only Q8W through Week 36 in the 8 mg Q8W group, Participant havin

Countries

Austria, Bulgaria, Czechia, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

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