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Scotoma Reduction in AMD Patients Treated With Ranibizumab (SALVAGE)

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ClinicalTrials.gov Identifier: NCT00467935
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : July 29, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: intravitreal injection Lucentis (ranibizumab) Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2007
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: intravitreal injection Lucentis (ranibizumab)
    intravitreal injection Lucentis (ranibizumab)

Outcome Measures

Primary Outcome Measures :
  1. scotoma reduction [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. improved visual function [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BCVA < 20/320
  • Disciform macular degeneration wiht exudation

Exclusion Criteria:

  • Non-amd CNV
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467935


Locations
United States, New York
Retina Research Center
Slingerlands, New York, United States, 12159
Sponsors and Collaborators
Retina Research Foundation
Investigators
Principal Investigator: Paul M Beer, MD Retina Research Foundation
More Information

Additional Information:
Responsible Party: Paul Beer, MD, Retina Consultants, PLLC
ClinicalTrials.gov Identifier: NCT00467935     History of Changes
Other Study ID Numbers: FVF3933
First Posted: May 1, 2007    Key Record Dates
Last Update Posted: July 29, 2011
Last Verified: July 2011

Keywords provided by Retina Research Foundation:
amd
disciform
fibrosis
Lucentis
scotoma

Additional relevant MeSH terms:
Macular Degeneration
Scotoma
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents