Clinical trial NCT02120950: Aflibercept in Polypoidal Choroidal Vasculopathy
Official title: A Randomized, Double-masked, Sham-controlled Phase 3b/4 Study of the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Monotherapy Compared to Aflibercept With Adjunctive Photodynamic Therapy as Indicated in Subjects With Polypoidal Choroidal Vasculopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neovascular Macular Degeneration
Keywords: PCV
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2014-04-23
Enrollment: 333
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: 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)
timeFrame: From Baseline to Week 52
Secondary outcomes:
measure: Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52
timeFrame: At Week 52
Other outcomes:
measure: Percentage of Subjects Who Never Need Rescue Therapy in the First Year
timeFrame: Baseline to Week 52
measure: Number of PDT Treatments in the Study Eye Before Week 52
timeFrame: Baseline to Week 52
measure: Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52
timeFrame: Baseline to Week 52
measure: Time to First Administration of PDT in the Study Eye Before Week 52
timeFrame: Baseline to Week 52
measure: Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye
timeFrame: Baseline to Week 52
measure: Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Subjects With Complete Polyp Regression at Week 52
timeFrame: Baseline to Week 52
measure: Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52
timeFrame: Baseline to Week 52
measure: Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52
timeFrame: Baseline to Week 52
Locations:
city: Liverpool
country: Australia
state: New South Wales
city: Strathfield
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: East Melbourne
country: Australia
state: Victoria
city: Parramatta
country: Australia
city: München
country: Germany
city: Hong Kong
country: Hong Kong
city: Kowloon
country: Hong Kong
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Nagoya
country: Japan
state: Aichi
city: Urayasu
country: Japan
state: Chiba
city: Ogaki
country: Japan
state: Gifu
city: Maebashi
country: Japan
state: Gunma
city: Asahikawa
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Kita
country: Japan
state: Kagawa
city: Tsu
country: Japan
state: Mie
city: Kashihara
country: Japan
state: Nara
city: Hirakata
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Otsu
country: Japan
state: Shiga
city: Hamamatsu
country: Japan
state: Shizuoka
city: Shimotsuke
country: Japan
state: Tochigi
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Akita
country: Japan
city: Aomori
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Kyoto
country: Japan
city: Nagasaki
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Tokushima
country: Japan
city: Wakayama
country: Japan
city: Seongnam-si
country: Korea, Republic of
state: Gyeonggido
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Changhua City
country: Taiwan
state: Changhua
city: Kaohsiung
country: Taiwan
city: Taipei City
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Lee WK, Iida T, Ogura Y, Chen SJ, Wong TY, Mitchell P, Cheung GCM, Zhang Z, Leal S, Ishibashi T; PLANET Investigators. Efficacy and Safety of Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in the PLANET Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2018 Jul 1;136(7):786-793. doi: 10.1001/jamaophthalmol.2018.1804.