Trial Condition(s):

Neovascular Macular Degeneration

Aflibercept in polypoidal choroidal vasculopathy (PLANET)

Bayer Identifier:

16995

ClinicalTrials.gov Identifier:

NCT02120950

EudraCT Number:

2013-004464-54

Study Completed

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

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.

Trial Summary

Enrollment Goal
333
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Sapporo, Japan, 060-8604

Status
Completed
 
Locations

Investigative Site

Fukushima, Japan, 960-1295

Status
Completed
 
Locations

Investigative Site

Shimotsuke, Japan, 329-0498

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
Locations

Investigative Site

Urayasu, Japan, 279-0021

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
Locations

Investigative Site

Maebashi, Japan, 371-8511

Status
Completed
 
Locations

Investigative Site

Hamamatsu, Japan, 430-8558

Status
Completed
 
Locations

Investigative Site

Tsu, Japan, 514-8507

Status
Completed
 
Locations

Investigative Site

Kashihara, Japan, 634-8522

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 606-8507

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 602-0841

Status
Completed
 
Locations

Investigative Site

Suita, Japan, 565-0871

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 545-8586

Status
Completed
 
Locations

Investigative Site

Hirakata, Japan, 573-1191

Status
Completed
 
Locations

Investigative Site

Okayama, Japan, 700-8558

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Investigative Site

Nagasaki, Japan, 852-8511

Status
Completed
 
Locations

Investigative Site

Akita, Japan, 010-8543

Status
Completed
 
Locations

Investigative Site

Kowloon, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

München, Germany, 80336

Status
Completed
 
Locations

Investigative Site

Westmead, Australia, 2145

Status
Completed
 
Locations

Investigative Site

East Melbourne, Australia, 3002

Status
Completed
 
Locations

Investigative Site

Parramatta, Australia, 2150

Status
Completed
 
Locations

Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1133

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1082

Status
Completed
 
Locations

Investigative Site

Budapest, Hungary, 1106

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 10449

Status
Completed
 
Locations

Investigative Site

Changhua City, Taiwan, China, 500

Status
Completed
 
Locations

Investigative Site

Kaohsiung, Taiwan, China, 81362

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 10002

Status
Completed
 
Locations

Investigative Site

Taipei, Taiwan, China, 11217

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8655

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 137-701

Status
Completed
 
Locations

Investigative Site

Seongnam-si, South Korea, 463-707

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 03080

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 05505

Status
Completed
 
Locations

Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-0011

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 466-8560

Status
Completed
 
Locations

Investigative Site

Asahikawa, Japan, 078-8510

Status
Completed
 
Locations

Investigative Site

Amagasaki, Japan, 660-8550

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 860-0027

Status
Completed
 
Locations

Investigative Site

Tokushima, Japan, 770-8503

Status
Completed
 
Locations

Investigative Site

Seoul, South Korea, 153-950

Status
Completed
 
Locations

Investigative Site

Chiba, Japan, 260-8677

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 168751

Status
Completed
 
Locations

Investigative Site

Singapore, Singapore, 119074

Status
Completed
 
Locations

Investigative Site

Liverpool, Australia, 2170

Status
Completed
 
Locations

Investigative Site

Strathfield, Australia, 2135

Status
Completed
 
Locations

Investigative Site

Otsu, Japan, 520-2192

Status
Completed
 
Locations

Investigative Site

Taipei City, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Kita, Japan, 761-0793

Status
Completed
 
Locations

Investigative Site

Meguro-ku, Japan, 152-8902

Status
Completed
 
Locations

Investigative Site

Aomori, Japan, 030-8553

Status
Completed
 
Locations

Investigative Site

Wakayama, Japan, 641-8510

Status
Completed
 
Locations

Investigative Site

Ogaki, Japan, 503-0015

Status
Completed
 
Locations

Investigative Site

Chiyoda-ku, Japan, 101-8309

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 650-0017

Status
Completed
 

Trial Design