Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis
Phase II Study Intravitreally Admininstered Ranibizumab in 50 Subjects With AMD Having Received at Least 3 Doses of Intermittent Anti-VEGF Therapy in the Preceding 18 Months
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 5, 2008
CompletedFirst Posted
Study publicly available on registry
December 9, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedMay 28, 2012
May 1, 2012
Same day
December 5, 2008
May 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change in visual acuity at 6 and 12 months
one year
Study Arms (1)
0
Interventions
Eligibility Criteria
You may qualify if:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age greater then and equal 50 years
- Patients with active neovascular AMD
- Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months
- If the patient has bilateral disease and qualifies for the study, both eyes may be included
You may not qualify if:
- Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy or lactation
- Premenopausal women not using adequate contraception.
- Participation in another simultaneous medical investigation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Retina Institute of Hawaii
Honolulu, Hawaii, 96815, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Debra L Shimabukuro, RN
Retina Institute of Hawaii
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2008
First Posted
December 9, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2008
Study Completion
January 1, 2009
Last Updated
May 28, 2012
Record last verified: 2012-05