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
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, see Learn About Clinical Studies.

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 August 28, 2014