UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058082 |
|---|---|
| Receipt number | R000066382 |
| Scientific Title | Evaluation of high-dose aflibercept therapy, aqueous humor cytokine changes, and prognostic factors in patients with age-related macular degeneration |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/06/04 21:49:31 |
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Basic information
Public title
Evaluation of high-dose aflibercept therapy, aqueous humor cytokine changes, and prognostic factors in patients with age-related macular degeneration
Acronym
Evaluation of high-dose aflibercept therapy in patients with age-related macular degeneration
Scientific Title
Evaluation of high-dose aflibercept therapy, aqueous humor cytokine changes, and prognostic factors in patients with age-related macular degeneration
Scientific Title:Acronym
Evaluation of high-dose aflibercept therapy in patients with age-related macular degeneration
Region
| Japan |
Condition
Condition
Neovascular age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy of high-dose aflibercept therapy for neovascular age-related macular degeneration and to analyze cytokine concentrations in aqueous humor obtained at the initiation of treatment. By examining their associations with clinical outcomes such as visual acuity, central retinal thickness, and lesion size, the study seeks to identify potential prognostic biomarkers. In addition, by comparing aqueous humor cytokine profiles between nAMD eyes and control eyes undergoing cataract surgery, the study aims to identify disease-specific cytokine alterations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in best-corrected visual acuity from baseline at week 48
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
nAMD group: Patients diagnosed with age-related macular degeneration who will receive high-dose aflibercept treatment
Control group: Patients undergoing ophthalmic surgery
Key exclusion criteria
Cases with comorbid inflammatory diseases such as uveitis
Cases that have undergone treatment at another institution with insufficient clinical details
Cases in which aqueous humor sampling via anterior chamber paracentesis is judged to be unsafe
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Hikaru |
| Middle name | |
| Last name | Ota |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
466-8560
Address
65 Tsurumachi, Showa-ku, Nagoya-shi, Aichi
TEL
052-741-2111
hikaru.betty@gmail.com
Public contact
Name of contact person
| 1st name | Hikaru |
| Middle name | |
| Last name | Ota |
Organization
Nagoya University Hospital
Division name
Ophthalmology
Zip code
4668560
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture, Japan
TEL
052-741-2111
Homepage URL
hikaru.betty@gmail.com
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya university hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya City, Aichi Prefecture, Japan
Tel
052-741-2111
ethics@med.nagoya-u.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
| 2026 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066382
