UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033786 |
|---|---|
| Receipt number | 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 22:33:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
daejoongma@gmail.com
Sponsor or person
Institute
Seoul National University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
