Status:
COMPLETED
Lucentis in Advanced Macular Degeneration
Lead Sponsor:
Steven R. Sanislo
Collaborating Sponsors:
Genentech, Inc.
California Pacific Medical Center
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual fu...
Detailed Description
The duration of the study is up to 13 months. This includes up to 30 days during which tests will be performed before treatment. Only one eye will be chosen for the study. Patients can receive up to 1...
Eligibility Criteria
Inclusion
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- Age \> 50 years.
- Low vision AMD patients with a VA of 20/400 or worse.
- Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT or fresh appearing subretinal hemorrhage on fundus examination.
Exclusion
- Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy (positive pregnancy test) or lactation.
- Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Participation in another simultaneous medical investigation or trial.
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00896779
Start Date
October 1 2009
End Date
September 1 2013
Last Update
June 29 2015
Active Locations (2)
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1
California Pacific Medical Center
San Francisco, California, United States, 94107
2
Stanford University School of Medicine
Stanford, California, United States, 94305