Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
333 participants
INTERVENTIONAL
2014-05-29
2017-07-07
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aflibercept + Sham PDT
Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus sham photodynamic therapy (only in subjects qualifying for rescue therapy)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Eylea is administered as an intravitreal injection
Aflibercept + Active PDT
Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every month for the first 3 months (run-in period). At Week 12, subjects were randomized to receive Aflibercept injection plus active photodynamic therapy (only in subjects qualifying for rescue therapy)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Eylea is administered as an intravitreal injection
Visudyne
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Interventions
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Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Eylea is administered as an intravitreal injection
Visudyne
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Liverpool, New South Wales, Australia
Strathfield, New South Wales, Australia
Westmead, New South Wales, Australia
East Melbourne, Victoria, Australia
Parramatta, , Australia
München, , Germany
Hong Kong, , Hong Kong
Kowloon, , Hong Kong
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Nagoya, Aichi-ken, Japan
Urayasu, Chiba, Japan
Ōgaki, Gifu, Japan
Maebashi, Gunma, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Amagasaki, Hyōgo, Japan
Kobe, Hyōgo, Japan
Kita, Kagawa-ken, Japan
Tsu, Mie-ken, Japan
Kashihara, Nara, Japan
Hirakata, Osaka, Japan
Suita, Osaka, Japan
Ōtsu, Shiga, Japan
Hamamatsu, Shizuoka, Japan
Shimotsuke, Tochigi, Japan
Bunkyo-ku, Tokyo, Japan
Chiyoda-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Mitaka, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Akita, , Japan
Aomori, , Japan
Chiba, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Fukushima, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Kyoto, , Japan
Nagasaki, , Japan
Okayama, , Japan
Osaka, , Japan
Tokushima, , Japan
Wakayama, , Japan
Singapore, , Singapore
Singapore, , Singapore
Seongnam-si, Gyeonggido, South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Changhua, Changhua, Taiwan
Kaohsiung City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Countries
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References
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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.
Related Links
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Other Identifiers
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2013-004464-54
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16995
Identifier Type: -
Identifier Source: org_study_id