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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
Retina Research Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring amd, disciform, fibrosis, Lucentis, scotoma

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 29, 2007
Last Updated
July 28, 2011
Sponsor
Retina Research Foundation
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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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