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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Retina Institute of Hawaii
ClinicalTrials.gov Identifier:
NCT00804934
First received: December 5, 2008
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Wet AMD
Drug: Lucentis
Phase 2

Study Type: Observational
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Retina Institute of Hawaii:

Primary Outcome Measures:
  • Mean change in visual acuity at 6 and 12 months [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
0 Drug: Lucentis
0.5mg Lucentis every four months

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804934

Locations
United States, Hawaii
Retina Institute of Hawaii
Honolulu, Hawaii, United States, 96815
Sponsors and Collaborators
Retina Institute of Hawaii
Investigators
Study Chair: Debra L Shimabukuro, RN Retina Institute of Hawaii
  More Information

No publications provided

Responsible Party: Retina Institute of Hawaii
ClinicalTrials.gov Identifier: NCT00804934     History of Changes
Other Study ID Numbers: F4421S
Study First Received: December 5, 2008
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 22, 2014