Scotoma Reduction in AMD Patients Treated With Ranibizumab (SALVAGE)

This study has been completed.
Sponsor:
Information provided by:
Retina Research Foundation
ClinicalTrials.gov Identifier:
NCT00467935
First received: April 29, 2007
Last updated: July 28, 2011
Last verified: July 2011
  Purpose

This is a trial aimed at patients with advanced wet macular degeneration and macular scarring treated wiht intravitreal injections of Lucentis.


Condition Intervention Phase
Macular Degeneration
Drug: intravitreal injection Lucentis (ranibizumab)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Retina Research Foundation:

Primary Outcome Measures:
  • scotoma reduction [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improved visual function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: intravitreal injection Lucentis (ranibizumab)
    intravitreal injection Lucentis (ranibizumab)
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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-amd CNV
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Paul Beer, MD, Retina Consultants, PLLC
ClinicalTrials.gov Identifier: NCT00467935     History of Changes
Other Study ID Numbers: FVF3933
Study First Received: April 29, 2007
Last Updated: July 28, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014