Observational Study to Evaluate the occurrence of Age-Related Macular Degeneration (AMD) in Japanese Patients with genetic deficiency of Cholesteryl Ester Transfer Protein (CETP)

JRCT ID: jRCT1050230058

Registered date:25/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with homozygous CETP deficiency
• Date of first enrollment: 06/09/2023
• Target sample size: 15
• Study type: Observational

Outcome(s)

• Primary Outcome: occurence of AMD

Key inclusion & exclusion criteria

• Age minimum: >= 50age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients who give written consent by using a ICF approved by the Institutional Review Board or Independent Ethics Committee of the observational study site before starting procedures related to the observational study.
2)Male and female patients who are aged 50 years or older at the time of obtaining written consent
3)Patients with any of the following:
a)deficiency of cholesteryl ester transfer protein based on genetic test results
b)Patients with a CETP level of less than or equal to1.0 (microgram/milliliter) who may be diagnosed with a homozygous gene deficiency of cholesteryl ester transfer protein (CETP)

• Exclude criteria: Patients who are unable to undergo ophthalmologic examination

Related Information

• Primary Sponsor: Shiba Mariko
• Secondary Sponsor: Kanmuri Kazuhiro,New Amsterdam Pharma BV