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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00395551
First Posted: November 3, 2006
Last Update Posted: January 8, 2010
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.
Collaborator:
Genentech, Inc.
Information provided by:
Ophthalmic Consultants of Boston
  Purpose
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
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 ClinicalTrials.gov identifier (NCT number): NCT00395551


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

Responsible Party: Dr. Jeffrey S. Heier, Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier: NCT00395551     History of Changes
Other Study ID Numbers: FVF 3688 Non-AMD
First Submitted: November 1, 2006
First Posted: November 3, 2006
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:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents