A STUDY OF FARICIMAB WITH ANGIOID STREAKS.

JRCT ID: jRCT2071220090

Registered date:18/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Angioid Streaks
• Date of first enrollment: 30/03/2023
• Target sample size: 23
• Study type: Interventional
• Intervention(s): RO6867461 (faricimab) : The dose of faricimab (genetical recombination) is 6.0 mg by intravitreal injection at a minimum interval of 4 weeks. If Angioid Streaks occur in the non-test eye and the investigator determines that treatment is necessary, 6.0 mg of faricimab (recombinant) is injected intravitreous in the non-test eye at a minimum of 4-week intervals.

Outcome(s)

Primary Outcome

Efficacy
Change from baseline in BCVA score at Week 12

Secondary Outcome

Efficacy
Change in BCVA from baseline over time, change from baseline at Week 52
Change in proportion of subjects with improved BCVA
Change in percentage of subjects who avoided a decrease in BCVA
Change in the proportion of subjects with BCVA greater than or equal to 20/40 and less than or equal to 20/200 by Snellen's formula
Number of injections of study drug received by Week 52
Time from last dose of consecutive doses to relapse
Number of relapses by Week 52
Change in CST from baseline over time, Week 12, and Week 52
Proportion of subjects without intraretinal exudate, subretinal fluid, or intraretinal cysts
Change from baseline in total CNV lesion area and total CNV leakage area at Week 12 and Week 52
Safety
Incidence and severity of ocular adverse events
Incidence and severity of non-ocular adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients with AS with CNV
Patients with CNV lesions involving the central macular region
Patients with CNV lesions with at least one of the following findings
-Active CNV confirmed by FA (evidence of leakage)
-Exudation from CNV confirmed by OCT (presence of serous fluid)
Patients with a BCVA of 24 to 78 letters on ETDRS visual acuity test (approximately equivalent to 20/320 to 20/32 in the Snellen formula, with a decimal visual acuity of 0.0625 to 0.625) evaluated at a starting distance of 4 m on Day 1
Patients with a sufficiently clear intermediate translucent body and pupils sufficiently dilated to allow good-quality retinal imaging for definitive diagnosis.
Women of childbearing potential: Patients who agree to abstinence (abstinence from heterosexual intercourse) or use of a contraceptive method with an annual contraceptive failure rate of less than 1% during the period of treatment with faricimab and for 3 months after the last dose of study drug, and who agree to refrain from egg donation during this period.

Exclude criteria

Patients with CNV due to causes other than AS for the study eye
Patients with previous history of intravitreal injection of Faricimab (Vabysmo) for the study eye
Intravitreal injection of anti-VEGF within 3 months prior to Day 1 for the study eye
Patients with uncontrolled hypertension on Day 1 (uncontrolled hypertension is defined as resting systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg)
Patients who had a stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1
Patients with a history or complication of other diseases, metabolic dysfunction, physical examination findings, or laboratory findings that, in the opinion of the investigator, may contraindicate the use of the study drug, may affect the interpretation of study results, or may be sufficiently suspicious to increase the risk of treatment complications
Pregnant or lactating women, or women who wish to become pregnant during the study or within 3 months after the last administration of faricimab
Patients with a history of severe allergic or anaphylactic reactions to biological products or known hypersensitivity to any component of faricimab, study procedures, mydriatic eye drops, anesthetics used by the patient during the study, or antibacterial agents
Patients who have participated in a clinical trial using drugs (excluding vitamins and minerals) or devices for treatment within 3 months prior to Day 1

Related Information

• Primary Sponsor: Iida Tomohiro