A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration

A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration - A phase III study to evaluate the equivalence in efficacy and safety of SJP-0133 to Lucentis in patients with age-related macular degeneration

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030010

Enrollment

338

Registered

2017-11-22

Start date

2017-11-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exudative age-related macular degeneration

Interventions

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. Three intravi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes in best-corrected visual acuity	—

Countries

Japan

Contacts

Public ContactTakuro Sekiya

Senju Pharmaceutical Co.,Ltd. Clinical Development

t-sekiya@senju.co.jp078-777-1018

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026