Aflibercept in Polypoidal Choroidal Vasculopathy (PLANET)

November 17, 2020 updated by: Bayer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
333

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Parramatta, Australia, 2150
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
      • Strathfield, New South Wales, Australia, 2135
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
  • Germany
      • München, Germany, 80336
  • Hong Kong
      • Hong Kong, Hong Kong
      • Kowloon, Hong Kong
  • Hungary
      • Budapest, Hungary, 1082
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1133
      • Debrecen, Hungary, 4032
  • Japan
      • Akita, Japan, 010-8543
      • Aomori, Japan, 030-8553
      • Chiba, Japan, 260-8677
      • Fukuoka, Japan, 812-8582
      • Fukuoka, Japan, 812-0011
      • Fukushima, Japan, 960-1295
      • Kumamoto, Japan, 860-0027
      • Kyoto, Japan, 606-8507
      • Kyoto, Japan, 602-0841
      • Nagasaki, Japan, 852-8511
      • Okayama, Japan, 700-8558
      • Osaka, Japan, 545-8586
      • Tokushima, Japan, 770-8503
      • Wakayama, Japan, 641-8510
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
    • Chiba
      • Urayasu, Chiba, Japan, 279-0021
    • Gifu
      • Ogaki, Gifu, Japan, 503-0015
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
      • Sapporo, Hokkaido, Japan, 060-8604
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8550
      • Kobe, Hyogo, Japan, 650-0017
    • Kagawa
      • Kita, Kagawa, Japan, 761-0793
    • Mie
      • Tsu, Mie, Japan, 514-8507
    • Nara
      • Kashihara, Nara, Japan, 634-8522
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
      • Suita, Osaka, Japan, 565-0871
    • Shiga
      • Otsu, Shiga, Japan, 520-2192
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8558
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
      • Chiyoda-ku, Tokyo, Japan, 101-8309
      • Meguro-ku, Tokyo, Japan, 152-8902
      • Mitaka, Tokyo, Japan, 181-8611
      • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Shinjuku-ku, Tokyo, Japan, 160-8582
  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 03080
      • Seoul, Korea, Republic of, 135-710
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 153-950
    • Gyeonggido
      • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
  • Singapore
      • Singapore, Singapore, 119074
      • Singapore, Singapore, 168751
  • Taiwan
      • Kaohsiung, Taiwan, 81362
      • Taipei, Taiwan, 11217
      • Taipei, Taiwan, 10002
      • Taipei, Taiwan, 10449
      • Taipei City, Taiwan
    • Changhua
      • Changhua City, Changhua, Taiwan, 500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Aflibercept + Sham PDT
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)
Eylea is administered as an intravitreal injection
Experimental: Aflibercept + Active PDT
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)
Eylea is administered as an intravitreal injection
Other: Visudyne
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52
Time Frame: 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.
At Week 52

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Who Never Need Rescue Therapy in the First Year
Time Frame: Baseline to Week 52
Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.
Baseline to Week 52
Number of PDT Treatments in the Study Eye Before Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Time to First Administration of PDT in the Study Eye Before Week 52
Time Frame: Baseline to Week 52
Baseline to Week 52
Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye
Time Frame: Baseline to 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.
Baseline to Week 52
Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52
Time Frame: Baseline to 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.
Baseline to Week 52
Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52
Time Frame: Baseline to 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.
Baseline to Week 52
Percentage of Subjects With Complete Polyp Regression at Week 52
Time Frame: Baseline to Week 52
Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye.
Baseline to Week 52
Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52
Time Frame: Baseline to Week 52
Leakage is the release of fluorescein dye from diseased retinal vessels. Leakage area is defined as the area showing presence of fluorescein dye in the late stages of fluorescein angiography.
Baseline to Week 52
Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52
Time Frame: Baseline to Week 52
Retinal and lesion characteristics, such as central retinal thickness (CRT), were evaluated by OCT in both eyes at every study visit. CRT was measured using optical coherence tomography to determine the average thickness of the retina in a circle with 1 millimeter of diameter centered on the fovea. This value is reported by some OCT devices as central subfield thickness (CST).
Baseline to Week 52
Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52
Time Frame: Baseline to Week 52
The NEI VFQ-25 total score ranges from 0-100 with a score of 0 being the worst outcome and 100 being the best outcome. The NEI VFQ questionnaire is organized as a collection of subscales which are all scored from 0-100. To reach the overall composite score, each sub-scale score is averaged in order to give each sub-scale equal weight.
Baseline to Week 52
Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52
Time Frame: Baseline to Week 52
Evaluations for qualification for rescue were conducted at each visit from Week 12 to Week 52. Intensified aflibercept treatment plus active or sham PDT treatments were given at any of these visits if treatment criteria were met. Qualification for rescue was based upon insufficient gain of BCVA, leakage, and presence of active polyps.
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 12, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16995
  • 2013-004464-54 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

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