UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051561 |
|---|---|
| Receipt number | R000058827 |
| Scientific Title | Changes in subfoveal choroidal thickness after intravitreal Aflibercept for diabetic macular edema. |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/07/09 16:51:46 |
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Basic information
Public title
A clinical trial to study the effects of Aflibercept in patients with type 2 diabetes mellitus with reduced vision.
Acronym
DM
Scientific Title
Changes in subfoveal choroidal thickness after intravitreal Aflibercept for diabetic macular edema.
Scientific Title:Acronym
DME
Region
| Asia(except Japan) |
Condition
Condition
Diabetic Macular Edema
Classification by specialty
| Endocrinology and Metabolism | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in subfoveal thickness after intervention at 3, 6, and 9 months after 3rd injection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
Reduction in subfoveal thickness after intravitreal Aflibercept
Key secondary outcomes
Improvement in vision after intervention
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravitreal injection of 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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
250u
Key exclusion criteria
Patients with proliferative diabetic retinopathy, prior intravitreal injections of anti-VEGFs or laser photocoagulation, pars plana vitrectomy, age-related macular degeneration, venous occlusion, ocular trauma, pregnancy, and ocular surgery (except cataract surgery) were excluded. Patients with less than 6 months follow-up after the 3rd injection were excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Rahul |
| Middle name | |
| Last name | Bhargava |
Organization
GS Medical College
Division name
Pilkhuwa
Zip code
245304
Address
NH9, Pilkhuwa, UP, India
TEL
+911204259971
dean@gsmedicalcollege.in
Public contact
Name of contact person
| 1st name | Prachi |
| Middle name | |
| Last name | Kumar |
Organization
Yashoda
Division name
Ghaziabad
Zip code
201012
Address
Near Metro station Kaushambi
TEL
+911204181900
Homepage URL
kumarprachi@yahoo.co.in
Sponsor or person
Institute
MMU Mullana Ambala
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MMU Mullana
Address
Ambala
Tel
+911731274476
pstoregistrar@mmumullana.org
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
| 2024 | 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
| 2022 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 09 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058827
