Phase 4 N=333 Randomized Quadruple-blind Treatment

Aflibercept in Polypoidal Choroidal Vasculopathy

Neovascular Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02120950 ↗

Enrolled (actual)

333

Serious AEs

16.8%

Results posted

Jan 2019

Primary outcome: Primary: Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF) — 10.7; 10.8 Letters correctly read — p=0.5480

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug); Visudyne (Other)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores From Baseline to Week 52 - Last Observation Carried Forward (LOCF)	10.7; 10.8	0.5480
SECONDARY Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52	97.5; 96.9	0.7402

Summary

To collect data reflecting the efficacy and safety of aflibercept with and without photodynamic therapy in subjects diagnosed with the polypoidal choroidal vasculopathy subtype of wet age-related macular degeneration

Eligibility Criteria

Inclusion Criteria

Signed informed consent
Men and women ≥50 years of age
Diagnosis of symptomatic macular Polypoidal Choroidal Vasculopathy (PCV) in the study eye established by Indocyanine Green Angiography(ICGA) at the study center
Greatest linear dimension of the lesion of < 5400 mm (approximately, 9 Macular Photocoagulation Study disk areas), assessed by ICGA.
An Early treatment diabetic retinopathy study (ETDRS) BCVA of 73 to 24 letters in the study eye.

Exclusion Criteria

Prior use of intravitreal or sub-tenon corticosteroids in the study eye within 3 months prior to study entry
Any prior use of intraocular anti Vascular Endothelial Growth Factor (anti-VEGF)agents in the study eye, or systemic use of anti VEGF products within 3 months prior to study entry
Prior macular laser treatment in the study eye including Photodynamic Therapy (PDT)
History of allergy to fluorescein used in fluorescein angiography, iodine and/or indocyanine green.
History of allergy to aflibercept, verteporfin, or their excipients.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02120950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.