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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033786
Receipt No. R000038544
Scientific Title Outcomes of intravitreal aflibercept (Eylea) treatment for treatment-naive contralateral eyes with neovascular age-related macular degeneration in patients whose treatment failed intravitreal ranibizumab in the first eye
Date of disclosure of the study information 2020/03/31
Last modified on 2018/08/16

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Basic information
Public title Outcomes of intravitreal aflibercept (Eylea) treatment for treatment-naive contralateral eyes with neovascular age-related macular degeneration in patients whose treatment failed intravitreal ranibizumab in the first eye
Acronym Fixed-Interval Versus As-Needed Dosing of Anti-Vascular Endothelial Growth Factor for Bilateral Neovascular Age-Related Macular Degeneration
Scientific Title Outcomes of intravitreal aflibercept (Eylea) treatment for treatment-naive contralateral eyes with neovascular age-related macular degeneration in patients whose treatment failed intravitreal ranibizumab in the first eye
Scientific Title:Acronym Fixed-Interval Versus As-Needed Dosing of Anti-Vascular Endothelial Growth Factor for Bilateral Neovascular Age-Related Macular Degeneration
Region
Asia(except Japan)

Condition
Condition Neovascular age-related macular degeneration
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of fixed-interval (proactive) and as-needed (reactive) dosing of anti-vascular endothelial growth factor (VEGF) treatment in patients with bilateral neovascular age-related macular degeneration (nAMD).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary outcome measures were the changes in BCVA, CMT, and retinal morphology, including the presence of SRF, IRF, and PED between the baseline and month 12.
Key secondary outcomes The secondary outcome included the proportion that met the criteria of poor response after the 12-month treatment and the frequency distribution of the changes in retinal morphology. The outcome measures were evaluated in the first and second eye groups, respectively, and compared between the groups.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The second eyes were treated with the 12-month fixed-interval dosing of aflibercept (3-monthly loading injections followed by bimonthly injections)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who showed poor response to the 12-month as-needed dosing anti-VEGF treatment (3-monthly loadings followed by further injections as required) in their first eyes were prospectively recruited. Poor response was defined as follows: reduction of central macular thickness (CMT) < 25%, with persistence or new subretinal fluid (SRF) or intraretinal fluid (IRF), or change in best-corrected visual acuity (BCVA) < 5 letters.
Key exclusion criteria 1) patients with neovascularized maculopathies other than AMD, 2) patients with a history of prior photocoagulation, intravitreal anti-VEGF injection, photodynamic therapy, intravitreal or sub-tenon steroid injection, vitrectomy surgery, or intravitreal gas injection, 3) patients with diabetic retinopathy or retinal vein occlusion, and 4) patients with coexisting epiretinal membranes or vitreomacular traction syndrome.
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hyeong Gon Yu
Organization Seoul National University Hospital
Division name Department of Ophthalmology
Zip code
Address 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea
TEL 82-2072-2053
Email 82959@snuh.org

Public contact
Name of contact person
1st name
Middle name
Last name DAE JOONG MA
Organization Seoul National University Hospital
Division name Department of Ophthalmology
Zip code
Address 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea
TEL 82-10-5092-9659
Homepage URL
Email daejoongma@gmail.com

Sponsor
Institute Seoul National University Hospital
Institute
Department

Funding Source
Organization Bayer Korea.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Republic of Korea

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Seoul National University Hospital

Other administrative information
Date of disclosure of the study information
2020 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 16 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038544

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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