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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003931
Receipt No. R000004723
Scientific Title Intravitreal injection of Pegaptanib(Macugen) for chronic central serous chorioretinopathy
Date of disclosure of the study information 2010/07/25
Last modified on 2014/12/13

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Basic information
Public title Intravitreal injection of Pegaptanib(Macugen) for chronic central serous chorioretinopathy
Acronym Pegaptanib for chronic central serous chorioretinopathy
Scientific Title Intravitreal injection of Pegaptanib(Macugen) for chronic central serous chorioretinopathy
Scientific Title:Acronym Pegaptanib for chronic central serous chorioretinopathy
Region
Japan

Condition
Condition Chronic central serous chorioretinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of intravitreal injection of Pegaptanib in the treatment of chronic central serous chorioretinopathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Proportion of subjects improved in best-corrected distance visual acuity (BCVA) at 24 weeks after initiation of pegaptanib.
Key secondary outcomes 1)Mean change in best corrected visual acuity (BCVA) from baseline at 24 weeks.
2)Proportion of subjects who lose less than 15 letters of BCVA from baseline at 24 weeks.
3)Anatomical change by OCT and fluorescein angiography.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 To Evaluate the efficacy of 0.3 mg dose of Pegaptanib in the treatment of chronic central serous retinopathy (CSC).
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
30 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)A history of persistent central serous chorioretinopathy present for at least 3 months.
2)Serous neurosensory detachment in the macula, and typical dye leakage pattern in fluorescein angiography.
3)Documented subfoveal fluid by OCT.
4)No signs of choroidal neovascularization.
5)The ability and willingness to provide written informed consent.
Key exclusion criteria 1)Prior treatment with laser or PDT.
2)Signs of choroidal neovascularization.
3)Intra ocular surgeries within 3 month prior to screening, in the study eye.
4)Previously vitrectomized eyes.
5)Past history of systemic disease such as:
Diabetic retinopathy.
Mild to severe heart failure (Class III or IV assessed by using the New York Heart Association Functional Classification (NYHA)), unstable angina, acute coronary syndrome, myocardial infarction, or ventricular tachycardia
Clinically significant peripheral vascular disease (amputation or symptoms of claudication)
Renal failure.
Liver failure.
Cerebral infarction within the preceding 12 months.
6)Previously received radiation therapy to the affected eye.
7)Severe allergic reactions to sodium fluorescein dye, indocyanine green dye or Pegaptanib.
8)Pregnancy or potential pregnancy.
9)Unwilling or unable to follow or comply with all study related procedures.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoko Ozawa
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsuro Uchida
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email atsuro@tt.rim.or.jp

Sponsor
Institute Department of Ophthalmology, Keio University School of Medicine
Institute
Department

Funding Source
Organization Department of Ophthalmology, Keio University School of Medicine
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
Address
Tel
Email

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 25 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
2010 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 12 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 20 Day
Last modified on
2014 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004723

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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