UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003931 |
|---|---|
| Receipt number | 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 14:55:50 |
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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
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
atsuro@tt.rim.or.jp
Sponsor or person
Institute
Department of Ophthalmology, Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004723
