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NCT01824225 Clinical Trial

Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration

Age-related Macular Degeneration Clinical Trial

Official title:
Study of PRN and Every 2months Intravitreal Aflibercept After 3 Initial Monthly Injection for Age Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01824225
Other study ID # NihonU-2
Secondary ID
Status Completed
Phase Phase 4
First received March 31, 2013
Last updated October 5, 2015
Start date March 2013
Est. completion date March 2015

Study information
Verified date October 2015
Source Nihon University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date March 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of age-related macular degeneration

Exclusion Criteria:

- Any treatment before intravitreal Aflibercept for age-related macular degeneration.

- Visual acuity above 0.1 in decimal visual acuity

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Aflibercept

Locations
Country Name City State
Japan Surugadai Nihon university hospital Chiyoda-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Nihon University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept one year Yes
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