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:
Collaborator:
Genentech
Information provided by:
Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier:
NCT00395551
First received: November 1, 2006
Last updated: January 7, 2010
Last verified: January 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395551

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

No publications provided

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
Study First Received: November 1, 2006
Last Updated: January 7, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 14, 2014