Status:
TERMINATED
Clinical Assessment Of Age-related Macular Degeneration Patients After Early Diagnosis and Treatment With Ranibizumab
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
To determine if patients treated early after diagnosis of wet age-related macular degeneration can return/maintain to their baseline pre-disease BCVA.
Detailed Description
We will conduct an open label, multi-center study of naïve AMD patients that are identified early upon disease progression (had a normal VA, FA or OCT within 4 months prior to entry) to assess if trea...
Eligibility Criteria
Inclusion
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age \> 50 years
- Naïve wet-AMD within 4 months of disease onset (for GALLEY patients) and within 3 months of disease onset for all others
- Patients that have lost \> 5 letters from baseline best vision
- BCVA 20/25-20/320
Exclusion
- 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 which includes an intervention (Patients could be participating in a non-interventional study such as the GALLEY study)
- Juxtafoveal and extrafoveal wet-AMD
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01402544
Start Date
July 1 2011
End Date
March 1 2015
Last Update
August 28 2019
Active Locations (4)
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1
California Retina Consultants
Bakersfield, California, United States, 93309
2
Shiley Eye Center, UCSD
La Jolla, California, United States, 92093
3
California Retina Consultants
Santa Barbara, California, United States, 93103
4
Medical Center Ophthalmology Associates
San Antonio, Texas, United States, 78240