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Aflibercept in Polypoidal Choroidal Vasculopathy (PLANET)

Primary Purpose

Neovascular Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Visudyne
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Macular Degeneration focused on measuring PCV

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Aflibercept + Sham PDT

Aflibercept + Active PDT

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 10, 2014
Last Updated
November 17, 2020
Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02120950
Brief Title
Aflibercept in Polypoidal Choroidal Vasculopathy
Acronym
PLANET
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 29, 2014 (Actual)
Primary Completion Date
August 12, 2016 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Macular Degeneration
Keywords
PCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
333 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aflibercept + Sham PDT
Arm Type
Experimental
Arm Description
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)
Arm Title
Aflibercept + Active PDT
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Intervention Description
Eylea is administered as an intravitreal injection
Intervention Type
Other
Intervention Name(s)
Visudyne
Intervention Description
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
From Baseline to Week 52
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52
Description
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.
Time Frame
At Week 52
Other Pre-specified Outcome Measures:
Title
Percentage of Subjects Who Never Need Rescue Therapy in the First Year
Description
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.
Time Frame
Baseline to Week 52
Title
Number of PDT Treatments in the Study Eye Before Week 52
Time Frame
Baseline to Week 52
Title
Number of Aflibercept Treatments in the Study Eye (After Randomization) Before Week 52
Time Frame
Baseline to Week 52
Title
Time to First Administration of PDT in the Study Eye Before Week 52
Time Frame
Baseline to Week 52
Title
Change of Visual Acuity (Letters) From Baseline Over Time (Week) in the Study Eye
Description
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.
Time Frame
Baseline to Week 52
Title
Percentage of Subjects Who Gained ≥5, 10, or 15 Letters at Week 52
Description
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.
Time Frame
Baseline to Week 52
Title
Percentage of Subjects Who Lost ≥5, 10, or 15 Letters at Week 52
Description
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.
Time Frame
Baseline to Week 52
Title
Percentage of Subjects With Complete Polyp Regression at Week 52
Description
Complete polyp regression was defined as absent or indeterminate visual polyps on Indocyanine green angiography (ICGA) in the study eye.
Time Frame
Baseline to Week 52
Title
Change of Leakage Area in Fluorescein Angiography (FA) in the Study Eye at Week 52
Description
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.
Time Frame
Baseline to Week 52
Title
Change of Central Subfield Thickness (CST) on Optical Coherence Tomography (OCT) From Baseline to Week 52
Description
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).
Time Frame
Baseline to Week 52
Title
Change in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) Total Score From Baseline to Week 52
Description
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.
Time Frame
Baseline to Week 52
Title
Percentage of Subjects for Whom Rescue Therapy is Indicated Over the Course Till Week 52
Description
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.
Time Frame
Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
City
Parramatta
ZIP/Postal Code
2150
Country
Australia
City
München
ZIP/Postal Code
80336
Country
Germany
City
Hong Kong
Country
Hong Kong
City
Kowloon
Country
Hong Kong
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
City
Urayasu
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
City
Ogaki
State/Province
Gifu
ZIP/Postal Code
503-0015
Country
Japan
City
Maebashi
State/Province
Gunma
ZIP/Postal Code
371-8511
Country
Japan
City
Asahikawa
State/Province
Hokkaido
ZIP/Postal Code
078-8510
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8604
Country
Japan
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-8550
Country
Japan
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
City
Kita
State/Province
Kagawa
ZIP/Postal Code
761-0793
Country
Japan
City
Tsu
State/Province
Mie
ZIP/Postal Code
514-8507
Country
Japan
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1191
Country
Japan
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
City
Otsu
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
430-8558
Country
Japan
City
Shimotsuke
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
City
Akita
ZIP/Postal Code
010-8543
Country
Japan
City
Aomori
ZIP/Postal Code
030-8553
Country
Japan
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-0011
Country
Japan
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
City
Kumamoto
ZIP/Postal Code
860-0027
Country
Japan
City
Kyoto
ZIP/Postal Code
602-0841
Country
Japan
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
City
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
City
Seongnam-si
State/Province
Gyeonggido
ZIP/Postal Code
463-707
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
153-950
Country
Korea, Republic of
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
City
Changhua City
State/Province
Changhua
ZIP/Postal Code
500
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
City
Taipei City
Country
Taiwan
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29801063
Citation
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. Erratum In: JAMA Ophthalmol. 2018 Jul 1;136(7):840.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217261&amp;parentIdentifier=16995&amp;attachmentIdentifier=6557dbc1-0000-454b-9bbc-69a823522784&amp;fileName=16995_Study_Synopsis_CTP.pdf&amp;versionIdentifier=
Description
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Aflibercept in Polypoidal Choroidal Vasculopathy

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