Scotoma Reduction in AMD Patients Treated With Ranibizumab - Full Text View

Sponsored by:	Retina Research Foundation
Information provided by:	Retina Research Foundation
ClinicalTrials.gov Identifier:	NCT00467935

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 I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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

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
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Sponsor

This link exits the ClinicalTrials.gov site

sponsor

Responsible Party:	Retina Consultants, PLLC ( Paul Beer, MD )
Study ID Numbers:	FVF3933
Study First Received:	April 29, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00467935
Health Authority:	United States: Food and Drug Administration

Keywords provided by Retina Research Foundation:

amd
disciform
fibrosis
Lucentis
scotoma

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Vision Disorders
Fibrosis
Eye Diseases
Neurologic Manifestations

Retinal Degeneration
Macular Degeneration
Scotoma
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009