Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis

May 24, 2012 updated by: Retina Institute of Hawaii

Phase II Study Intravitreally Admininstered Ranibizumab in 50 Subjects With AMD Having Received at Least 3 Doses of Intermittent Anti-VEGF Therapy in the Preceding 18 Months

The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine mean change in visual acuity at 6 and 12 months

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96815
        • Retina Institute of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age greater then and equal 50 years
  • Patients with active neovascular AMD
  • Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months
  • If the patient has bilateral disease and qualifies for the study, both eyes may be included

Exclusion Criteria:

  • Subjects who meet any of the following criteria will be excluded from this study:
  • Pregnancy or lactation
  • Premenopausal women not using adequate contraception.
  • Participation in another simultaneous medical investigation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Intervention / Treatment
Drug: Lucentis
0.5mg Lucentis every four months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in visual acuity at 6 and 12 months
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retina Institute of Hawaii

Investigators

  • Study Chair: Debra L Shimabukuro, RN, Retina Institute of Hawaii

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 5, 2008

First Submitted That Met QC Criteria

December 8, 2008

First Posted (Estimate)

December 9, 2008

Study Record Updates

Last Update Posted (Estimate)

May 28, 2012

Last Update Submitted That Met QC Criteria

May 24, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F4421S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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