UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008630 |
|---|---|
| Receipt number | R000010141 |
| Scientific Title | Long-term Outcome of Intravitreal Ranibizumab Treatment, Compared with Photodynamic Therapy, in Patients with Polypoidal Choroidal Vasculopathy |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2013/08/16 14:58:56 |
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Basic information
Public title
Long-term Outcome of Intravitreal Ranibizumab Treatment, Compared with Photodynamic Therapy, in Patients with Polypoidal Choroidal Vasculopathy
Acronym
Long-term outcome of IVR for PCV
Scientific Title
Long-term Outcome of Intravitreal Ranibizumab Treatment, Compared with Photodynamic Therapy, in Patients with Polypoidal Choroidal Vasculopathy
Scientific Title:Acronym
Long-term outcome of IVR for PCV
Region
| Japan |
Condition
Condition
polypoidal choroidal vasculopathy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the functional outcomes of patients with polypoidal choroidal vasculopathy (PCV) who underwent intravitreal ranibizumab (IVR) treatment, compared with photodynamic therapy (PDT).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The BCVA between the pre- and postoperative BCVA at 3, 6, 12, 18, and 24 months after the initial treatment.
Key secondary outcomes
The differences between the pre- and postoperative BCVA.
The regression of polyps
Complications
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 and Female
Key inclusion criteria
The patients were initially treated with IVR or PDT at the Yokohama City University Medical Center between September 2005 and June 2010. The inclusion criteria were the presence of PCV; a treatment-naïve status; availability for follow-up at 24 months or longer after the first treatment; and a BCVA of 20/400 or better at baseline.
Key exclusion criteria
Patients who underwent PDT that was subsequently switched to ranibizumab monotherapy within 2 years were also excluded.
Patients with eye diseases that could potentially influence visual acuity.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Maiko Inoue |
Organization
Yokohama City University Medical Center
Division name
Ophthalmology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maiko Inoue |
Organization
Yokohama City University Medical Center
Division name
Ophthalmology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively evaluated the functional outcomes and polyp regressions of patients with PCV who underwent IVR treatment, compared with PDT, after a follow-up period of at least two years.
Management information
Registered date
| 2012 | Year | 08 | Month | 06 | Day |
Last modified on
| 2013 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010141
