check_circleStudy Completed

Neovascular Macular Degeneration

Bayer Identifier:

16995

ClinicalTrials.gov Identifier:

NCT02120950

EudraCT Number:

2013-004464-54

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

Both

Age

50 - N/A
  • -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.
  • - 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.

Trial summary

Enrollment Goal
333
Trial Dates
May 2014 - July 2017
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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Withdrawn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Withdrawn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 52
    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:
    At Week 52

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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