UMIN-CTR Clinical Trial

Basic information
Public title	The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema
Acronym	Ranibizumab treatment with lasers for focal DME
Scientific Title	The effect of intravitreal injection of ranibizumab before direct photocoagulation in the treatment of focal diabetic macular edema
Scientific Title:Acronym	Ranibizumab treatment with lasers for focal DME
Region	Japan

Condition
Condition	diabetic macular edema
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of intravitreal injection of ranibizumab for the treatment of diabetic macular edema.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	retinal thickness, visual acuity,
Key secondary outcomes	THe frequency of additional treatment

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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with type 1 or type 2 diabetes mellitus 20 years of age or older. Patients with fovea involving diabetic macular edema (judged with central subfield thickness on OCT). Patients with reduced visual acuity associated with diabetic macular edema. Patients with a central retinal thickness (CRT) of 300 um or more on the OCT retinal map (measured in mm) as an objective finding. Patients who are willing and able to visit the study site, as scheduled, and undergo scheduled examinations in this study Patients who can provide written voluntary consent to participate in this study after receiving adequate explanation.
Key exclusion criteria	A history of any intraocular surgery in the study eye within the previous 90 days It is considered difficult to improve visual acuity due to morphological changes Glaucoma with poor IOP control, a history of glaucoma filtering surgery, or scheduled filtering surgery in the study eye IOP of the study eye: more than 25 mmHg Myopia of -8D or greater Optic media in which it is difficult to obtain fundus photographs or OCT images Severe systemic infections at baseline Systemic anticoagulation therapy within 180 Poorly controlled diabetes mellitus Poorly controlled hypertension A history of cerebrovascular accident and/or myocardial infarction within 180 days Patients on dialysis and patients with renal failure requiring dialysis
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Takamura
Organization	University of Fukui
Division name	Ophthalmology
Zip code	910-1193
Address	23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL	0776618403
Email	takamurayoshihiro@gmail.com

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Takamura
Organization	University of Fukui
Division name	Ophthalmology
Zip code	910-1193
Address	23-3 Shimoaizuki Matsuoka Yoshida Fukui
TEL	0776618403
Homepage URL
Email	takamurayoshihiro@gmail.com

Sponsor
Institute	University of Fukui, Ophthalmology
Institute
Department

Funding Source
Organization	University of Fukui, Ophthalmology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	2

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Fukui
Address	23-3 Shimoaizuki Matsuoka Yoshida Fukui
Tel	0776-61-8403
Email	takamurayoshihiro@gmail.com

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	2019 Year 02 Month 13 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	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 31 Day
Date of IRB	2015 Year 02 Month 18 Day
Anticipated trial start date	2019 Year 02 Month 09 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 02 Month 10 Day
Last modified on	2021 Year 02 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040816