Aflibercept in Polypoidal Choroidal Vasculopathy

NCT02120950 | Completed Phase 4 Results

• 2 other identifiers: 169952013-004464-54
• Study Type: interventional
• Target: 333
• Locations: 8 countries
• Sites: 62

Brief 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

Conditions

Neovascular Macular Degeneration

Keywords

PCV

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline to Week 52

Secondary Outcomes (1)

• Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52

  At Week 52

Other Outcomes (12)

• Percentage of Subjects Who Never Need Rescue Therapy in the First Year

  Baseline to Week 52

• Number of PDT Treatments in the Study Eye Before Week 52

  Baseline to Week 52

• Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52

  Baseline to Week 52

Study Arms (2)

Aflibercept + Sham PDT

EXPERIMENTAL

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)

Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)

Aflibercept + Active PDT

EXPERIMENTAL

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)

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

Interventions

Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) DRUG

Eylea is administered as an intravitreal injection

Aflibercept + Active PDT; Aflibercept + Sham PDT

Visudyne OTHER

Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

Aflibercept + Active PDT

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (62)

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Liverpool, New South Wales, 2170, Australia

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Strathfield, New South Wales, 2135, Australia

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Westmead, New South Wales, 2145, Australia

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East Melbourne, Victoria, 3002, Australia

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Parramatta, 2150, Australia

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München, 80336, Germany

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Hong Kong, Hong Kong

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Kowloon, Hong Kong

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Budapest, 1082, Hungary

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Budapest, 1106, Hungary

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Budapest, 1133, Hungary

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Debrecen, 4032, Hungary

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Nagoya, Aichi-ken, 466-8560, Japan

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Urayasu, Chiba, 279-0021, Japan

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Ōgaki, Gifu, 503-0015, Japan

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Maebashi, Gunma, 371-8511, Japan

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Asahikawa, Hokkaido, 078-8510, Japan

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Sapporo, Hokkaido, 060-8604, Japan

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Amagasaki, Hyōgo, 660-8550, Japan

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Kobe, Hyōgo, 650-0017, Japan

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Kita, Kagawa-ken, 761-0793, Japan

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Tsu, Mie-ken, 514-8507, Japan

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Kashihara, Nara, 634-8522, Japan

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Hirakata, Osaka, 573-1191, Japan

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Suita, Osaka, 565-0871, Japan

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Ōtsu, Shiga, 520-2192, Japan

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Hamamatsu, Shizuoka, 430-8558, Japan

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Shimotsuke, Tochigi, 329-0498, Japan

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Bunkyo-ku, Tokyo, 113-8655, Japan

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Chiyoda-ku, Tokyo, 101-8309, Japan

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Meguro-ku, Tokyo, 152-8902, Japan

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Mitaka, Tokyo, 181-8611, Japan

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Shinjuku-ku, Tokyo, 160-8582, Japan

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Shinjuku-ku, Tokyo, 162-8666, Japan

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Akita, 010-8543, Japan

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Aomori, 030-8553, Japan

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Chiba, 260-8677, Japan

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Fukuoka, 812-0011, Japan

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Fukuoka, 812-8582, Japan

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Fukushima, 960-1295, Japan

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Kumamoto, 860-0027, Japan

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Kyoto, 602-0841, Japan

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Kyoto, 606-8507, Japan

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Nagasaki, 852-8511, Japan

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Okayama, 700-8558, Japan

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Osaka, 545-8586, Japan

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Tokushima, 770-8503, Japan

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Wakayama, 641-8510, Japan

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Singapore, 119074, Singapore

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Singapore, 168751, Singapore

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Seongnam-si, Gyeonggido, 463-707, South Korea

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Seoul, 03080, South Korea

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Seoul, 05505, South Korea

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Seoul, 135-710, South Korea

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Seoul, 137-701, South Korea

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Seoul, 153-950, South Korea

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Changhua, Changhua, 500, Taiwan

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Kaohsiung City, 81362, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 10449, Taiwan

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Taipei, 11217, Taiwan

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Taipei, Taiwan

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Related Publications (1)

• 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.

  PMID: 29801063 DERIVED

Related Links

• Related Info

MeSH Terms

Interventions

aflibercept; Verteporfin

Intervention Hierarchy (Ancestors)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayer.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 23, 2014
• Study Start: May 29, 2014
• Primary Completion: August 12, 2016
• Study Completion: July 7, 2017
• Last Updated: December 2, 2020
• Results First Posted: January 15, 2019

Record last verified: 2020-11

Locations

SG (2); AU (5); JP (36); HU (4); DE (1); TW (6); KR (6); HK (2)