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CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Washington University School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00500344
First received: July 10, 2007
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

CNV from AMD is the leading cause of blindness in people over 50 in North America. The hypothesis is to determine if there is an improvement in retinal function determined by ERG following treatment with ranibizumab for AMD


Condition Intervention Phase
Age-Related Macular Degeneration
Drug: Lucentis (ranibizumab)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CAPTAIN: Choroidal Neovascularization Assessment by Pattern Electroretinography After Ranibizumab in Naive Age-Related Macular Degeneration Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • To determine if there is an improvement in retinal function determined by the ERG following treatment with ranibizumab [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if there is an improvement in visual acuity and retinal function as determined by ERG [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Correlation between change in PERG and mean change in VA at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Mean change in VA from baseline to 0 months and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Lucentis (ranibizumab)
intravitreal injection

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age ≥ 50 years
  • Treatment naive AMD patients that are determined to be candidates for ranibizumab
  • Visual acuity 20/40 to 20/320

Exclusion Criteria:

  • Pregnancy
  • Prior enrollment in the study
  • Previous therapy for AMD or other retinal diseases which may be used in the treatment of AMD
  • Any other condition that the investigator believes would pose a significant hazard to the subject if on-label ranibizumab were prescribed
  • Any condition that would interfere with the ERG recording (such as media opacities including lens or corneal opacity)
  • Concurrent eye disease in the study eye that could compromise visual acuity (such as diabetic retinopathy, advanced glaucoma)
  • Any condition causing the patient to have a significant tremor that would interfere with the patient's ability to remain still during the ERG (such as Parkinson's disease)
  • Participation in another simultaneous medical investigation or trial
  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: NCT00500344

Locations
United States, Missouri
Barnes Retina Institute
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Genentech, Inc.
Investigators
Principal Investigator: Rajendra S. Apte, MD, PhD Washington University School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rajendra Apte, MD, PhD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00500344     History of Changes
Other Study ID Numbers: FVF4184S
Study First Received: July 10, 2007
Last Updated: February 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Washington University School of Medicine:
Age-related Macular Degeneration
Choroidal Neovascularization
Electroretinography
Retinal Function

Additional relevant MeSH terms:
Choroidal Neovascularization
Macular Degeneration
Neovascularization, Pathologic
Choroid Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on November 25, 2014