UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002405
Receipt number R000002950
Scientific Title Photodynamic therapy with one third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial
Date of disclosure of the study information 2009/10/01
Last modified on 2014/05/17 17:03:15

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Basic information

Public title

Photodynamic therapy with one third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial

Acronym

Photodynamic therapy with one third dose verteporfin for central serous chorioretinopathy

Scientific Title

Photodynamic therapy with one third dose verteporfin for central serous chorioretinopathy:Prospective intervention trial

Scientific Title:Acronym

Photodynamic therapy with one third dose verteporfin for central serous chorioretinopathy

Region

Japan


Condition

Condition

Central serous chorioretinopathy

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of one third dose verteporfin photodynamic therapy(PDT) with half dose for central serous chorioretinopathy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

resolution of serous retinal detachment of 4 days, 1 month, 3 months, 6 months, and 1 year after PDT

Key secondary outcomes

1)visual acuity
2)thickness of retina and serous retinal detachment at fovea on optical coherence tomography
3)choroidal thickness on optical coherence tomography
4)amplitudes and implicit time of a-wave, b-wave and odcillatory potentials recorded by focal macula electroretinogram
5)visual field
6)fluorescein angiography
7)indocyanine green angiography

time of assessment
1)-5) : 4 days, 1 month, 3 months, 6 months, and 1 year after PDT
6),7) : 1 month, 3 months, and 1 year after PDT


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

2mg/m2 intravenous infusion of verteporfin over 10 minutes followed by delivery of diode laser at 689nm 15 minutes after the start of the infusion.
Light dose rate is 600 mW/cm2, time of photosensitization is 83 seconds, and total light energy is 50J/cm2.

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. 3 months or more after onset
2. presence of active angiographic leakage under or adjacent to fovea
in fluorescein angiography
3. presence of serous retinal detachment(SRD) on optical coherence tomography(OCT)
4. written informed consent
5. re-treatment is considered to the patients with recurrent or persistent SRD on OCT

Key exclusion criteria

1. drug allery to verteporfin
2. pregnant or expecting pregnancy
3. porphyria, or hypersensitivity to artificial illumination
4. macular diseases other than CSC
5. others (inappropriate case judged by investigator or subinvestigators)

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohei Ishikawa

Organization

Nagoya University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture

TEL

052-741-2111

Email

kokecha@juno.dti.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ruka Maruko

Organization

Nagoya University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture

TEL

052-741-2111

Homepage URL


Email

rutia@xg8.so-net.ne.jp


Sponsor or person

Institute

Nagoya University School of Medicine Department of Ophthalmology

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

名古屋大学医学部附属病院(愛知県)


Other administrative information

Date of disclosure of the study information

2009 Year 10 Month 01 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

2009 Year 08 Month 17 Day

Date of IRB


Anticipated trial start date

2009 Year 08 Month 01 Day

Last follow-up date

2011 Year 01 Month 01 Day

Date of closure to data entry

2011 Year 01 Month 01 Day

Date trial data considered complete

2011 Year 01 Month 01 Day

Date analysis concluded

2011 Year 01 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 08 Month 30 Day

Last modified on

2014 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002950


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name