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

Wet AMD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00804934
• Other study ID #: F4421S
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2008
• Last updated: May 24, 2012
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: May 2012
• Source: Retina Institute of Hawaii
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Wet AMD

Intervention

Drug:
• Lucentis
0.5mg Lucentis every four months

Locations

Country	Name	City	State
United States	Retina Institute of Hawaii	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Retina Institute of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in visual acuity at 6 and 12 months		one year	No