Scotoma Reduction in AMD Patients Treated With Ranibizumab (SALVAGE)
Primary Purpose
Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
intravitreal injection Lucentis (ranibizumab)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring amd, disciform, fibrosis, Lucentis, scotoma
Eligibility Criteria
Inclusion Criteria:
- BCVA < 20/320
- Disciform macular degeneration wiht exudation
Exclusion Criteria:
- Non-amd CNV
Sites / Locations
- Retina Research Center
Outcomes
Primary Outcome Measures
scotoma reduction
Secondary Outcome Measures
improved visual function
Full Information
NCT ID
NCT00467935
First Posted
April 29, 2007
Last Updated
July 28, 2011
Sponsor
Retina Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00467935
Brief Title
Scotoma Reduction in AMD Patients Treated With Ranibizumab
Acronym
SALVAGE
Official Title
A Phase I/II Study to Evaluate Scotoma Reduction in And Limited Visual Acuity in aGe Related Macular Degeneration Patients Treated With Intravitreal Lucentis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Retina Research Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.
Detailed Description
Patients with severe wet macular degeneration and scarring in the center of the retina may benefit from treatment if the size of the blind spot is reduced wiht injections of Lucentis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
amd, disciform, fibrosis, Lucentis, scotoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
intravitreal injection Lucentis (ranibizumab)
Intervention Description
intravitreal injection Lucentis (ranibizumab)
Primary Outcome Measure Information:
Title
scotoma reduction
Time Frame
12 months
Secondary Outcome Measure Information:
Title
improved visual function
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BCVA < 20/320
Disciform macular degeneration wiht exudation
Exclusion Criteria:
Non-amd CNV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul M Beer, MD
Organizational Affiliation
Retina Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina Research Center
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.retinaresearchfoundation.org
Description
Sponsor
URL
http://retinaconsultants.org
Description
sponsor
Learn more about this trial
Scotoma Reduction in AMD Patients Treated With Ranibizumab
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