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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02120950




Registration number
NCT02120950
Ethics application status
Date submitted
10/04/2014
Date registered
23/04/2014
Date last updated
2/12/2020

Titles & IDs
Public title
Aflibercept in Polypoidal Choroidal Vasculopathy
Scientific 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
Secondary ID [1] 0 0
2013-004464-54
Secondary ID [2] 0 0
16995
Universal Trial Number (UTN)
Trial acronym
PLANET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Other interventions - Visudyne

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)

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)


Treatment: Drugs: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
Eylea is administered as an intravitreal injection

Other interventions: Visudyne
Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
From Baseline to Week 52
Secondary outcome [1] 0 0
Percentage of Subjects Who Avoided at Least 15 Letters Loss in ETDRS at Week 52
Timepoint [1] 0 0
At Week 52

Eligibility
Key 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2017
Sample size
Target
Accrual to date
Final
333
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Liverpool
Recruitment hospital [2] 0 0
- Strathfield
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- East Melbourne
Recruitment hospital [5] 0 0
- Parramatta
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2135 - Strathfield
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment postcode(s) [5] 0 0
2150 - Parramatta
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
München
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Kowloon
Country [4] 0 0
Hungary
State/province [4] 0 0
Budapest
Country [5] 0 0
Hungary
State/province [5] 0 0
Debrecen
Country [6] 0 0
Japan
State/province [6] 0 0
Aichi
Country [7] 0 0
Japan
State/province [7] 0 0
Chiba
Country [8] 0 0
Japan
State/province [8] 0 0
Gifu
Country [9] 0 0
Japan
State/province [9] 0 0
Gunma
Country [10] 0 0
Japan
State/province [10] 0 0
Hokkaido
Country [11] 0 0
Japan
State/province [11] 0 0
Hyogo
Country [12] 0 0
Japan
State/province [12] 0 0
Kagawa
Country [13] 0 0
Japan
State/province [13] 0 0
Mie
Country [14] 0 0
Japan
State/province [14] 0 0
Nara
Country [15] 0 0
Japan
State/province [15] 0 0
Osaka
Country [16] 0 0
Japan
State/province [16] 0 0
Shiga
Country [17] 0 0
Japan
State/province [17] 0 0
Shizuoka
Country [18] 0 0
Japan
State/province [18] 0 0
Tochigi
Country [19] 0 0
Japan
State/province [19] 0 0
Tokyo
Country [20] 0 0
Japan
State/province [20] 0 0
Akita
Country [21] 0 0
Japan
State/province [21] 0 0
Aomori
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Fukushima
Country [24] 0 0
Japan
State/province [24] 0 0
Kumamoto
Country [25] 0 0
Japan
State/province [25] 0 0
Kyoto
Country [26] 0 0
Japan
State/province [26] 0 0
Nagasaki
Country [27] 0 0
Japan
State/province [27] 0 0
Okayama
Country [28] 0 0
Japan
State/province [28] 0 0
Tokushima
Country [29] 0 0
Japan
State/province [29] 0 0
Wakayama
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gyeonggido
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seoul
Country [32] 0 0
Singapore
State/province [32] 0 0
Singapore
Country [33] 0 0
Taiwan
State/province [33] 0 0
Changhua
Country [34] 0 0
Taiwan
State/province [34] 0 0
Kaohsiung
Country [35] 0 0
Taiwan
State/province [35] 0 0
Taipei City
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT02120950
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02120950