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Aflibercept in Polypoidal Choroidal Vasculopathy

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neovascular Macular Degeneration

Intervention: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) (Drug); Visudyne (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Phone: (+)1-888-84 22937, Email: clinical-trials-contact@bayerhealthcare.com

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change of ETDRS BCVA (Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity)

Secondary outcome: Number of participants of with a loss of less than 15-letter on BCVA scale

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

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 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.

Locations and Contacts

Bayer Clinical Trials Contact, Phone: (+)1-888-84 22937, Email: clinical-trials-contact@bayerhealthcare.com

Parramatta 2150, Australia; Recruiting

München 80336, Germany; Recruiting

Hong Kong, Hong Kong; Recruiting

Kowloon, Hong Kong; Recruiting

Budapest 1082, Hungary; Recruiting

Budapest 1106, Hungary; Recruiting

Budapest 1133, Hungary; Recruiting

Debrecen 4032, Hungary; Recruiting

Akita 010-8543, Japan; Recruiting

Aomori 030-8553, Japan; Recruiting

Chiba 260-8677, Japan; Recruiting

Fukuoka 812-0011, Japan; Recruiting

Fukuoka 812-8582, Japan; Recruiting

Fukushima 960-1295, Japan; Recruiting

Kumamoto 860-0027, Japan; Recruiting

Kumamoto 860-0035, Japan; Not yet recruiting

Kyoto 602-8566, Japan; Recruiting

Kyoto 606-8507, Japan; Recruiting

Nagasaki 852-8511, Japan; Recruiting

Okayama 700-8558, Japan; Recruiting

Osaka 545-8586, Japan; Recruiting

Osaka 558-8558, Japan; Not yet recruiting

Saitama 336-0963, Japan; Not yet recruiting

Tokushima 770-8503, Japan; Recruiting

Wakayama 641-8510, Japan; Recruiting

Seoul 135-710, Korea, Republic of; Recruiting

Seoul 110-744, Korea, Republic of; Not yet recruiting

Seoul 137-701, Korea, Republic of; Recruiting

Seoul 138-736, Korea, Republic of; Recruiting

Seoul 153-950, Korea, Republic of; Recruiting

Singapore 119074, Singapore; Recruiting

Singapore 168751, Singapore; Recruiting

Kaohsiung 81362, Taiwan; Recruiting

Taipei City, Taiwan; Recruiting

Taipei 10016, Taiwan; Recruiting

Taipei 10449, Taiwan; Recruiting

Taipei 11217, Taiwan; Recruiting

Taoyuan 333, Taiwan; Terminated

Nagoya, Aichi 467-8602, Japan; Not yet recruiting

Nagoya, Aichi 466-8560, Japan; Recruiting

Changhua City, Changhua 500, Taiwan; Recruiting

Urayasu, Chiba 279-0021, Japan; Recruiting

Matsuyama, Ehime 790-0024, Japan; Not yet recruiting

Kurume, Fukuoka 830-0011, Japan; Not yet recruiting

Koriyama, Fukushima 963-8052, Japan; Not yet recruiting

Ogaki, Gifu 503-0015, Japan; Recruiting

Maebashi, Gunma 371-8511, Japan; Recruiting

Seongnam-si, Gyeonggido 463-707, Korea, Republic of; Recruiting

Asahikwa, Hokkaido 078-8510, Japan; Recruiting

Sapporo, Hokkaido 006-8555, Japan; Not yet recruiting

Sapporo, Hokkaido 060-8604, Japan; Recruiting

Sapporo, Hokkaido 060-8648, Japan; Terminated

Amagasaki, Hyogo 660-0892, Japan; Recruiting

Kobe, Hyogo 650-0017, Japan; Recruiting

Kita, Kagawa 761-0793, Japan; Recruiting

Kaohsiung City, Kaohsiung 83301, Taiwan; Terminated

Tsu, Mie 514-8507, Japan; Recruiting

Sendai, Miyagi 980-8574, Japan; Not yet recruiting

Kashihara, Nara 634-8522, Japan; Recruiting

Liverpool, New South Wales 2170, Australia; Recruiting

Strathfield, New South Wales 2135, Australia; Recruiting

Westmead, New South Wales 2145, Australia; Recruiting

Göttingen, Niedersachsen 37075, Germany; Not yet recruiting

Hirakata, Osaka 573-1191, Japan; Recruiting

Suita, Osaka 565-0871, Japan; Recruiting

Otsu, Shiga 520-2192, Japan; Recruiting

Hamamatsu, Shizuoka 430-8558, Japan; Recruiting

Shimotsuke, Tochigi 329-0498, Japan; Recruiting

Bunkyo-ku, Tokyo 113-8655, Japan; Recruiting

Chiyoda-ku, Tokyo 101-8309, Japan; Recruiting

Meguro-ku, Tokyo 152-8902, Japan; Recruiting

Mitaka, Tokyo 181-8611, Japan; Recruiting

Shinjuku-ku, Tokyo 160-8582, Japan; Recruiting

Shinjuku-ku, Tokyo 162-8666, Japan; Recruiting

Imizu, Toyama 939-0243, Japan; Not yet recruiting

East Melbourne, Victoria 3002, Australia; Recruiting

Nedlands, Western Australia 6009, Australia; Not yet recruiting

Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: May 2014
Last updated: August 12, 2015

Page last updated: August 23, 2015

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