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Recruitment status Completed
Unique ID issued by UMIN UMIN000010260
Receipt No. R000012009
Scientific Title The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa via Subretinal Injection of The 3rd Generation of Recombinant Simian Immunodeficiency Virus (SIVagm) Vector Expressing Human Pigment Epithelium-Derived Factor (hPEDF) Gene
Date of disclosure of the study information 2013/03/26
Last modified on 2018/10/20

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Basic information
Public title The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa via Subretinal Injection of The 3rd Generation of Recombinant Simian Immunodeficiency Virus (SIVagm) Vector Expressing Human Pigment Epithelium-Derived Factor (hPEDF) Gene
Acronym The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa
Scientific Title The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa via Subretinal Injection of The 3rd Generation of Recombinant Simian Immunodeficiency Virus (SIVagm) Vector Expressing Human Pigment Epithelium-Derived Factor (hPEDF) Gene
Scientific Title:Acronym The Clinical Study for Neuroprotective Gene Therapy to Treat Patients with Retinitis Pigmentosa
Region
Japan

Condition
Condition Retinitis Pigmentosa
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety of the gene therapy for patients with retinitis pigmentosa via the 3rd generation of recombinant simian immunodeficiency virus (SIV) vector expressing human pigment epithelium-derived factor (hPEDF) gene
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes 1. Physical examination
2. Blood and urine analyses
3. Vital signs
4. Ophthalmic examination
5. Adverse events
6. Viral shedding
Key secondary outcomes 1. Best corrected visual acuity
2. Visual field measurement testing
3. VFQ25

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Gene
Interventions/Control_1 Subretinal injection of the 3rd generation of recombinant simian immunodeficiency virus (SIV) vector expressing human pigment epithelium-derived factor (hPEDF) gene (low titer group)
Interventions/Control_2 Subretinal injection of the 3rd generation of recombinant simian immunodeficiency virus (SIV) vector expressing human pigment epithelium-derived factor (hPEDF) gene (high titer group)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Subjects with retinitis pigmentosa
2. 40 years and above
3. Subjects who get a regular checkup at Kyushu University Hospital over 1 year
Key exclusion criteria 1. Human immunodeficiency virus (HIV) antibody-positive subjects
2. Blindness
3. Subjects with a macular complication of retinitis pigmentosa (eg: macular degeneration,macular edema, etc.)
4. A past history of glaucoma
5. Subjects with retinal or subretinal disorders
6. Subjected with severe allergy or its history.
7. Subjects receiving chronic hemodialysis therapy
8. Subjects who have severe heart dysfunction or faiure
9. Subjects who have hepatic dysfunction or cirrhosis
10. Subject who have active inflammatory diseases
11. Subjects who have experienced celebral hemorrhage or infarction 6 months prior to treatment
12. Subjects with hematopoietic disorders
13. Alcoholism and/or drug dependence
14. Female subjects with pregnant or doubt of pregnancy
15. Subjects who are diagnosed with cancer or are suspected to cancer
16. Subject who have recieved operative resection of malignant neoplasm 5 years prior to treatment
17. Subjects who disapprove of birth control during at least 12 months after the vector administration
18. Subjects who take the antiviral drug at the registration
19. Others
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koh-Hei Sonoda
Organization Kyushu University Hospital
Division name Department of Ophthalmology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-642-5648
Email sonodak@med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Ikeda
Organization Kyushu University Hospital
Division name Department of Ophthalmology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL 092-642-5648
Homepage URL
Email ymocl@pathol1.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2013 Year 03 Month 26 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
2012 Year 08 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2018 Year 09 Month 19 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 17 Day
Last modified on
2018 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012009


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