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Neovascular Macular DegenerationPhase 4PLANETNCT02120950

Aflibercept in Polypoidal Choroidal Vasculopathy

A Phase 4 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Visudyne in people with Neovascular Macular Degeneration, run by Bayer at 62 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Neovascular Macular Degeneration
What is being tested?
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Visudyne
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
62 sitesin 8 countries
Study dates
29 May 2014to 7 Jul 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

62 sites in 8 countries.

62 sites in 8 countries

Japan36 sites

  • Study site

    Akita, 010-8543

  • Study site

    Amagasaki, Hyōgo, 660-8550

  • Study site

    Aomori, 030-8553

  • Study site

    Asahikawa, Hokkaido, 078-8510

  • Study site

    Bunkyo-ku, Tokyo, 113-8655

  • Study site

    Chiba, 260-8677

  • Study site

    Chiyoda-ku, Tokyo, 101-8309

  • Study site

    Fukuoka, 812-0011

  • Study site

    Fukuoka, 812-8582

  • Study site

    Fukushima, 960-1295

  • Study site

    Hamamatsu, Shizuoka, 430-8558

  • Study site

    Hirakata, Osaka, 573-1191

  • Study site

    Kashihara, Nara, 634-8522

  • Study site

    Kita, Kagawa-ken, 761-0793

  • Study site

    Kobe, Hyōgo, 650-0017

  • Study site

    Kumamoto, 860-0027

  • Study site

    Kyoto, 602-0841

  • Study site

    Kyoto, 606-8507

  • Study site

    Maebashi, Gunma, 371-8511

  • Study site

    Meguro-ku, Tokyo, 152-8902

  • Study site

    Mitaka, Tokyo, 181-8611

  • Study site

    Nagasaki, 852-8511

  • Study site

    Nagoya, Aichi-ken, 466-8560

  • Study site

    Ōgaki, Gifu, 503-0015

  • Study site

    Okayama, 700-8558

  • Study site

    Osaka, 545-8586

  • Study site

    Ōtsu, Shiga, 520-2192

  • Study site

    Sapporo, Hokkaido, 060-8604

  • Study site

    Shimotsuke, Tochigi, 329-0498

  • Study site

    Shinjuku-ku, Tokyo, 160-8582

  • Study site

    Shinjuku-ku, Tokyo, 162-8666

  • Study site

    Suita, Osaka, 565-0871

  • Study site

    Tokushima, 770-8503

  • Study site

    Tsu, Mie-ken, 514-8507

  • Study site

    Urayasu, Chiba, 279-0021

  • Study site

    Wakayama, 641-8510

Other trials in Japan

South Korea6 sites

  • Study site

    Seongnam-si, Gyeonggido, 463-707

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 137-701

  • Study site

    Seoul, 153-950

Other trials in South Korea

Taiwan6 sites

  • Study site

    Changhua, Changhua, 500

  • Study site

    Kaohsiung City, 81362

  • Study site

    Taipei, 10002

  • Study site

    Taipei, 10449

  • Study site

    Taipei, 11217

  • Study site

    Taipei

Other trials in Taiwan

Australia5 sites

  • Study site

    East Melbourne, Victoria, 3002

  • Study site

    Liverpool, New South Wales, 2170

  • Study site

    Parramatta, 2150

  • Study site

    Strathfield, New South Wales, 2135

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Hungary4 sites

  • Study site

    Budapest, 1082

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Debrecen, 4032

Other trials in Hungary

Hong Kong2 sites

  • Study site

    Hong Kong

  • Study site

    Kowloon

Other trials in Hong Kong

Singapore2 sites

  • Study site

    Singapore, 119074

  • Study site

    Singapore, 168751

Other trials in Singapore

Germany1 site

  • Study site

    München, 80336

Other trials in Germany

About this study

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

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

Being tested
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321), Visudyne
Keywords
PCV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Eylea is administered as an intravitreal injection

  • VisudyneOther

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

Study groups in NCT02120950
Study groupRoleWhat they receive
Aflibercept + Sham PDTExperimentalParticipants 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)
Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Aflibercept + Active PDTExperimentalParticipants 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)
Receives: Drug: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321); Other: Visudyne

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Baseline to Week 52

Secondary outcomes (1)

  1. 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.

    Measured: At Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2014 (estimated)
  2. Study start29 May 2014
  3. Primary completion12 Aug 2016
  4. Study completion7 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120950
Sponsor's protocol ID
16995
Other IDs
2013-004464-54
Acronym
PLANET
Status last verified
Nov 2020
First submitted
10 Apr 2014
Last updated
2 Dec 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Teo KYC, Yoon YH, Honda S, Park KH, Takahashi H, Ideta R, Sekiryu T, Hirata A, Obana A, Mori R, Chen SJ, Chee C, Wong JG, Lai TYY, Wong I, Fung N, Lee WK, Terasaki H, Chen SC, Miyatani T, Iida T, Obata R, Machewitz T, Leal S, Cheung CMG. Six-Year Outcomes in Subjects with Polypoidal Choroidal Vasculopathy in the PLANET Study. Ophthalmol Ther. 2026 Jun;15(6):1907-1924. doi: 10.1007/s40123-026-01366-5. Epub 2026 Mar 28.

    PubMed 41903075

  • 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.

    PubMed 29801063

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) and Visudyne in people with Neovascular Macular Degeneration, run by Bayer at 62 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 sites in Japan, South Korea, Taiwan, Australia, Hungary and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From Baseline to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02120950, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.

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