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A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization

A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization - A phase 2, open-label study of S-646240 in patients with age-related macular degeneration accompanied by choroidal neovascularization

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008040
Enrollment
40
Registered
2012-05-29
Start date
2012-05-01
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

Age-related macular degeneration

Interventions

Patients will receive 2 mg (2 mL) of S-646240 subcutaneously in the cervical region or axilla every week from the initiation of study treatment to Week 4 and every two weeks from Week 4 to Week 22. Pa

Sponsors

Shionogi & Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients in whom active lesion of new-onset CNV in central retinal subfovea of the study eye which cause AMD was found by fluorescein angiography and indocyanine green angiography. (The study eye should be one eye or another.) (2) Patients whose BCVA score in the study eye, using ETDRS chart, is between 20/25 and 20/200 (between 80 and 35 of letter score).

Exclusion criteria

Exclusion criteria: (1) Patients who have CNV due to other causes than age. (2) Patients who have previous or present retinal vessel disease other than AMD.

Design outcomes

Primary

MeasureTime frame
Safety: The incidence of adverse event and adverse drug reaction. Efficacy: Change in best-corrected visual acuity (BCVA) scores in the study eye, using ETDRS chart.

Countries

Japan

Outcome results

None listed

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