Overview

CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
Genentech, Inc.
Treatments:
Ranibizumab
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