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

Email



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


Email



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


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



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name