Evaluation of optimum timing for intravitreal injection of aflibercept for age-related macular degeneration

UMIN ID: UMIN000014946

Registered date:07/07/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Wet age-related macular degeneration
• Date of first enrollment: 2014/07/08
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intravitreal aflibercept with traet and extend regimen
Intravitreal aflibercept every 8 weeks

Outcome(s)

• Primary Outcome: Proportion of eyes at week 52 that maintained best-corrected visual acuity (BCVA; lost <15 letters from baseline); change from baseline in BCVA.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Presence of other causes of CNV, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye. Active intraocular inflammation in the study eye. Active ocular or periocular infection in study eye. Uncontrolled glaucoma in the study eye. Prior treatment with anti VEGF therapy in the study eye. History of myocardial infarction or stroke in the past 3 months.

Related Information

• Primary Sponsor: Faculty of life sciences, Kumamoto university
• Source(s) of Monetary Support: Faculty of life sciences, Kumamoto university