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CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography (CAPTAIN)

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ClinicalTrials.gov Identifier: NCT00500344
Recruitment Status : Unknown
Verified February 2009 by Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : July 12, 2007
Last Update Posted : February 5, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Lucentis (ranibizumab) Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAPTAIN: Choroidal Neovascularization Assessment by Pattern Electroretinography After Ranibizumab in Naive Age-Related Macular Degeneration Patients
Study Start Date : July 2007
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : March 2009


Arms and Interventions

Arm Intervention/treatment
1 Drug: Lucentis (ranibizumab)
intravitreal injection


Outcome Measures

Primary Outcome Measures :
  1. To determine if there is an improvement in retinal function determined by the ERG following treatment with ranibizumab [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To determine if there is an improvement in visual acuity and retinal function as determined by ERG [ Time Frame: 6 months ]
  2. Correlation between change in PERG and mean change in VA at 6 months [ Time Frame: 6 months ]
  3. Mean change in VA from baseline to 0 months and 6 months [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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:
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
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: February 5, 2009
Last Verified: February 2009

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

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