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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395551
Recruitment Status : Completed
First Posted : November 3, 2006
Last Update Posted : January 8, 2010
Genentech, Inc.
Information provided by:
Ophthalmic Consultants of Boston

Brief 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.

Condition or disease Intervention/treatment Phase
Choroidal Neovascularization Drug: ranibizumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : December 2005
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Arm Intervention/treatment
Active Comparator: ranibizumab
ranibizumab 0.5mg intravitreal injection
Drug: ranibizumab
0.5mg intravitreal injection

Primary Outcome Measures :
  1. The primary outcome measures for safety and tolerability [ Time Frame: Mean change in visual acuity from baseline to 6 months & 12 months ]

Secondary Outcome Measures :
  1. The secondary outcome measures for efficacy [ Time Frame: 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • active choroidal neovascularization

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395551

Sponsors and Collaborators
Ophthalmic Consultants of Boston
Genentech, Inc.
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Principal Investigator: Jeffrey S Heier, M.D. Ophthalmic Consultants of Boston

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Responsible Party: Dr. Jeffrey S. Heier, Ophthalmic Consultants of Boston Identifier: NCT00395551     History of Changes
Other Study ID Numbers: FVF 3688 Non-AMD
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: January 8, 2010
Last Verified: January 2010
Keywords provided by Ophthalmic Consultants of Boston:
choroidal neovascularization
Choroidal Neovascularization Not related to Age-Related Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents