check_circleStudy Completed
Neovascular Macular Degeneration
Bayer Identifier:
16995
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Aflibercept in polypoidal choroidal vasculopathy
Trial purpose
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
Key Participants Requirements
Sex
BothAge
50 - N/ATrial summary
Enrollment Goal
333Trial Dates
May 2014 - July 2017Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Sapporo, 060-8604, Japan | |
Withdrawn | Sendai, 980-8574, Japan | |
Completed | Fukushima, 960-1295, Japan | |
Completed | Shimotsuke, 329-0498, Japan | |
Completed | Shinjuku-ku, 160-8582, Japan | |
Completed | Urayasu, 279-0021, Japan | |
Completed | Shinjuku-ku, 162-8666, Japan | |
Completed | Maebashi, 371-8511, Japan | |
Completed | Hamamatsu, 430-8558, Japan | |
Withdrawn | Nagoya, 467-8602, Japan | |
Completed | Tsu, 514-8507, Japan | |
Completed | Kashihara, 634-8522, Japan | |
Completed | Kyoto, 606-8507, Japan | |
Completed | Kyoto, 602-0841, Japan | |
Completed | Suita, 565-0871, Japan | |
Completed | Osaka, 545-8586, Japan | |
Completed | Hirakata, 573-1191, Japan | |
Completed | Okayama, 700-8558, Japan | |
Completed | Fukuoka, 812-8582, Japan | |
Completed | Nagasaki, 852-8511, Japan | |
Completed | Akita, 010-8543, Japan | |
Withdrawn | Saitama, 336-0963, Japan | |
Withdrawn | Imizu, 939-0243, Japan | |
Completed | Kowloon, Hong Kong | |
Completed | Hong Kong, Hong Kong | |
Completed | München, 80336, Germany | |
Withdrawn | Göttingen, 37075, Germany | |
Completed | Westmead, 2145, Australia | |
Withdrawn | Nedlands, 6009, Australia | |
Completed | East Melbourne, 3002, Australia | |
Completed | Parramatta, 2150, Australia | |
Completed | Debrecen, 4032, Hungary | |
Completed | Budapest, 1133, Hungary | |
Completed | Budapest, 1082, Hungary | |
Completed | Budapest, 1106, Hungary | |
Completed | Taipei, 10449, Taiwan | |
Completed | Changhua City, 500, Taiwan | |
Completed | Kaohsiung, 81362, Taiwan | |
Completed | Taipei, 10002, Taiwan | |
Withdrawn | Taoyuan, 333, Taiwan | |
Completed | Taipei, 11217, Taiwan | |
Completed | Bunkyo-ku, 113-8655, Japan | |
Completed | Seoul, 137-701, Korea, Republic Of | |
Completed | Seongnam-si, 463-707, Korea, Republic Of | |
Completed | Seoul, 135-710, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Mitaka, 181-8611, Japan | |
Withdrawn | Matsuyama, 790-0024, Japan | |
Completed | Fukuoka, 812-0011, Japan | |
Completed | Nagoya, 466-8560, Japan | |
Withdrawn | Sapporo, 006-8555, Japan | |
Withdrawn | Sapporo, 060-8648, Japan | |
Completed | Asahikawa, 078-8510, Japan | |
Withdrawn | Osaka, 558-8558, Japan | |
Completed | Amagasaki, 660-8550, Japan | |
Completed | Kumamoto, 860-0027, Japan | |
Completed | Tokushima, 770-8503, Japan | |
Withdrawn | Kurume, 830-0011, Japan | |
Completed | Seoul, 153-950, Korea, Republic Of | |
Completed | Chiba, 260-8677, Japan | |
Completed | Singapore, 168751, Singapore | |
Completed | Singapore, 119074, Singapore | |
Completed | Liverpool, 2170, Australia | |
Completed | Strathfield, 2135, Australia | |
Completed | Otsu, 520-2192, Japan | |
Withdrawn | Kaohsiung City, 83301, Taiwan | |
Completed | Taipei City, Taiwan | |
Withdrawn | Kumamoto, 860-0035, Japan | |
Completed | Kita, 761-0793, Japan | |
Completed | Meguro-ku, 152-8902, Japan | |
Withdrawn | Koriyama, 963-8052, Japan | |
Completed | Aomori, 030-8553, Japan | |
Completed | Wakayama, 641-8510, Japan | |
Completed | Ogaki, 503-0015, Japan | |
Completed | Chiyoda-ku, 101-8309, Japan | |
Completed | Kobe, 650-0017, Japan |
Primary Outcome
- 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)Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.date_rangeTime Frame:From Baseline to Week 52
Secondary Outcome
- Percentage of subjects who avoided at least 15 letters loss in ETDRS at Week 52Visual function of the study eye and fellow eye was assessed at each study visit according to the standard procedure developed for the ETDRS adapted for Age Related Eye Disease Study (AREDS), using 70 letter charts at a starting distance of 4 meters. Participants were challenged with reading letters on lines of an eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until they reached a row where a minimum of three letters on a line could be read, and were scored by how many letters could be correctly identified.date_rangeTime Frame:At Week 52
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2