Safety Study of Ranibizumab Eye Injections to Treat Choroidal Neovascularization That Was Caused Other Than by Age-Related Macular Degeneration.

Choroidal Neovascularization Clinical Trial

Official title:

A Single Center Study of the Safety and Efficacy of Multiple Intravitreal Injections of Ranibizumab in Subjects With CNV Secondary to Causes Other Than AMD.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395551
• Other study ID #: FVF 3688 Non-AMD
• Status: Completed
• Phase: Phase 1
• First received: November 1, 2006
• Last updated: January 7, 2010
• Start date: December 2005
• Est. completion date: June 2009

Study information

• Verified date: January 2010
• Source: Ophthalmic Consultants of Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether ranibizumab is effective in the treatment of choroidal neovascularization secondary to causes other then wet macular-degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• active choroidal neovascularization

Exclusion Criteria:

• pregnancy,age-related macular degeneration, current eye infection or recent eye surgery, participating in other eye studies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• ranibizumab
0.5mg intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Boston	Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measures for safety and tolerability		Mean change in visual acuity from baseline to 6 months & 12 months	Yes
Secondary	The secondary outcome measures for efficacy		Mean change in visual acuity from baseline to 6 & 12 months. Change in retinal thickness from baseline to week 1, month 1, 2, 3, 6, & 12 measured by OCT. Change in area of CNV from baseline to month 3, 6 & 12 measured by FA	No