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CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography (CAPTAIN)

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ClinicalTrials.gov Identifier: NCT00500344
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Rajendra S. Apte, Washington University School of Medicine

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 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
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009


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



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 ]


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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

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
Washington University
Saint 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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rajendra S. Apte, Rajendra S. 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: May 3, 2018
Last Verified: April 2018

Keywords provided by Rajendra S. Apte, 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