UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030010 |
|---|---|
| Receipt number | R000034245 |
| Scientific Title | A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration |
| Date of disclosure of the study information | 2017/11/22 |
| Last modified on | 2020/08/26 11:19:32 |
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Basic information
Public title
A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration
Acronym
A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration
Scientific Title
A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration
Scientific Title:Acronym
A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration
Region
| Japan |
Condition
Condition
Exudative age-related macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of SJP-0133 compared to Lucentis in patients with exudative age-related macular degeneration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in best-corrected visual acuity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Three intravitreal injections of 0.05 mL SJP-0133 once every 4 weeks from the start of treatment to Week 8 followed by pro re nata injections of 0.05 mL SJP-0133 from Week 12 to Week 48.
Interventions/Control_2
Three intravitreal injections of 0.05 mL Lucentis once every 4 weeks from the start of treatment to Week 8 followed by pro re nata injections of 0.05 mL SJP-0133 from Week 12 to Week 48.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Written informed consent obtained after adequate explanation on participating the study
2. Japanese male or female outpatient, 50 years of age or older at consent
3. Presence of subfoveal choroidal neovascularization associated with exudative age-related macular degeneration
Key exclusion criteria
1. Presence of subfoveal subretinal haemorrhage
2. Presence of subfoveal fibrosis or atrophic
3. Presence of retinal pigment epithelial tear
4. Presence of choroidal neovascularization associated with any other disease
5. Presence of any other retinochoroidal disease that would affect the assessment of visual acuity
6. Presence of vitreous haemorrhage
7. Prior treatment with any anti-VEGF agents
8. History of surgical intervention for age-related macular degeneration
9. History of allergy or significant adverse drug reaction to any ingredients of drugs used in this study
Target sample size
338
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mineo Kondo |
Organization
Mie University Graduate School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5027
mineo@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Sekiya |
Organization
Senju Pharmaceutical Co.,Ltd.
Division name
Clinical Development
Zip code
Address
6-4-3,Minatojima-Minamimachi,Chuo-Ku,Kobe,Hyogo,Japan
TEL
078-777-1018
Homepage URL
t-sekiya@senju.co.jp
Sponsor or person
Institute
Senju Pharmaceutical Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Senju Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 11 | Month | 22 | 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
| 2017 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 17 | Day |
Last modified on
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034245
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