Feasibility study for protein analysis

JRCT ID: jRCT1080222814

Registered date:31/03/2015

Basic Information

• Health condition(s) or Problem(s) studied: wet age-related macular degeneration
• Date of first enrollment: 31/03/2015
• Target sample size: 89
• Study type: Observational

Intervention(s)

investigational material(s)
Generic name etc : -
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

control material(s)
Generic name etc : -
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : -

Outcome(s)

Primary Outcome

Concentration of each protein in aqueous humor and serum between different 4 groups
Protein level in aqueous humor and serum is compared between the groups, respectively

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: <= 84age old
• Gender: Both

Include criteria

1)65 years old or more less than 85 years old
2)Presence of cataract
3)Presence of wet AMD in the either eye
4)Presence of wet AMD in the either eye and have well response to anti-VEGF drug intravitreal injection therapy
5)Presence of wet AMD in the either eye but have refractory against anti-VEGF drug intravitreal injection therapy

Exclude criteria

1)Presence of retinal disease expect wet AMD
2)History of vitreous surgery or PDT
3)Presence of active ocular infection
4)Presence of active ocular allergic disease
5)Have received intraocular operation expect vitreous surgery or PDT within 90 days prior to enrollment
6)Presence of cancer

Related Information

• Primary Sponsor: Fukushima Medical University
• Source(s) of Monetary Support: Santen pharmaceutical co.,ltd
• Secondary ID(s): JapicCTI-152866