UMIN-CTR Clinical Trial

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
Email	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
Email	t-sekiya@senju.co.jp

Sponsor
Institute	Senju Pharmaceutical Co.,Ltd.
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034245