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

• Sponsor: Retina Institute of Hawaii (Other)
• Overall Status: Completed
• CT.gov ID: NCT00804934
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Wet AMD	Drug: Lucentis

Detailed Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• 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
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
0	Drug: Lucentis; 0.5mg Lucentis every four months

Outcome Measures

Primary Outcome Measures

1. Mean change in visual acuity at 6 and 12 months [one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Retina Institute of Hawaii
• ClinicalTrials.gov Identifier: NCT00804934
• Other Study ID Numbers: F4421S
• First Posted: Dec 9, 2008
• Last Update Posted: May 28, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Ranibizumab

Study Results

No Results Posted as of May 28, 2012