UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010997 |
|---|---|
| Receipt number | R000012812 |
| Scientific Title | Intravitreal aflibercept injection for exudative age-related macular degeneration |
| Date of disclosure of the study information | 2013/06/19 |
| Last modified on | 2024/12/27 21:10:32 |
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Basic information
Public title
Intravitreal aflibercept injection for exudative age-related macular degeneration
Acronym
Intravitreal aflibercept injection for AMD
Scientific Title
Intravitreal aflibercept injection for exudative age-related macular degeneration
Scientific Title:Acronym
Intravitreal aflibercept injection for AMD
Region
| Japan |
Condition
Condition
Age-Related Macular Degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of aflibercept with three consecutive monthly injections for loading phase and bimonthly injections in AMD eyes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of maintained visual acuity at month 12
Key secondary outcomes
Change of best-corrected visual acuity (BCVA) and central retinal thickness.
Proportion of subretinal fluid and regression ofpolypoidal lesion.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eylea(aflibercept )
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)BCVA:0.1-0.5
2)AMD with subfoveal fluid on fluorescein angiography, indocyanine green angiography, and/or optical coherence tomography
3)Patients with willingness to provide written informed consent
4)Outpatients
Key exclusion criteria
1)The greatest linear dimension (GLD)>12 Macular Photocoagulation Study Disc Areas
2)Presence of subretinal hemorrhage, scar or macular fibrosis(>50% lesion area)
3)Prior treatment with anti-VEGF drugs, photodynamic therapy
4)Prior treatment with dexamethasone(within 6 months) or triamcinolone (within 30 days), intraocular surgery(within 3 months
5)Active intraocular inflammation
6)Hypersensitivity or allergy to fluoresceinor or indocyanine green, clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products
7)Patients who the doctor in charge judges are ineligible for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tetsuju |
| Middle name | |
| Last name | Sekiryu |
Organization
Fukushima Medical University School of Medicine
Division name
Ophthalmology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima 960-1295, Japan
TEL
024-547-1303
sekiryu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Saito |
Organization
Fukushima Medical University School of Medicine
Division name
Ophthalmology
Zip code
960-1295
Address
1 Hikarigaoka Fukushima
TEL
024-547-1303
Homepage URL
smasaaki@fmu.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Fukushima Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japa
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University School of Medicine
Address
1 Hikarigaoka, Fukushima 960-1295, Japan
Tel
+81-24-547-1825
rs@fmu.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/27660164/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/27660164/
Number of participants that the trial has enrolled
47
Results
The mean visual acuity in 27 eyes with typical AMD and 20 eyes with PCV significantly (p < 0.0001, p < 0.05, respectively) improved from 0.60 to 0.32 at baseline to 0.29 and 0.21 at month 12. At month 12, 22 (81.5 %) eyes with typical AMD and 17 (85 %) eyes with PCV had dry macula. Progressing or new GA was seen in three eyes with typical AMD and one eye with PCV; the mean change in the BCVA was significantly (p = 0.0026) worse at month 12. No other complications developed.
Results date posted
| 2024 | Year | 12 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We prospectively studied 47 eyes with AMD. Forty-seven patients (mean age 72.2 years) received three consecutive monthly intravitreal aflibercept injections followed by an injection every 2 months until 12 months. The primary outcome was the 12-month visual results compared with baseline; the secondary outcomes were the prevalence of geography atrophy (GA), a dry macula at month 12, and anatomic changes on optical coherence tomography.
Participant flow
All eyes received three consecutive monthly intravitreal aflibercept injections followed by an injection every 2 months until 12 months.
Adverse events
No complications developed, such as unexpected increasing subretinal hemorrhages (>1 disc diameter), RPE tears, ocular inflammation, increased intraocular pressure over 21 mmHg, severe visual loss, endophthalmitis, progression of cataract, or systemic adverse events.
Outcome measures
The primary outcome was the 12-month visual results compared with baseline; the secondary outcomes were the prevalence of geography atrophy (GA), a dry macula at month 12, and anatomic changes on optical coherence tomography.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2013 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012812
