UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hyeong Gon Yu
Organization	Seoul National University Hospital
Division name	Department of Ophthalmology
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	DAE JOONG MA
Organization	Seoul National University Hospital
Division name	Department of Ophthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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