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

This study has been completed.
Genentech, Inc.
Information provided by:
Ophthalmic Consultants of Boston Identifier:
First received: November 1, 2006
Last updated: January 7, 2010
Last verified: January 2010
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 Intervention Phase
Choroidal Neovascularization Drug: ranibizumab Phase 1

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Ophthalmic Consultants of Boston:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: December 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ranibizumab
ranibizumab 0.5mg intravitreal injection
Drug: ranibizumab
0.5mg intravitreal injection


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00395551

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

Responsible Party: Dr. Jeffrey S. Heier, Ophthalmic Consultants of Boston Identifier: NCT00395551     History of Changes
Other Study ID Numbers: FVF 3688 Non-AMD
Study First Received: November 1, 2006
Last Updated: January 7, 2010

Keywords provided by Ophthalmic Consultants of Boston:
choroidal neovascularization
Choroidal Neovascularization Not related to Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on August 22, 2017