Overview

Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration

Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study is to determine the safety & efficacy of ranibizumab for the treatment of retinal angiomatous proliferation secondary to age related macular degeneration.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
The National Retina Institute
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

- Definite characteristic signs of age related macular degeneration including drusen

- Presence of retinal angiomatous proliferation as determined by clinical signs (intra
retinal hemorrhage, retinal edema, cystic retinal edema) and angiography (occult
leakage on fluorescein angiography, hot spot on static ICG, visible RAP lesion of high
speed ICG)

Exclusion Criteria:

- Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary
thermotherapy in the study eye (predominantly classic CNV can however only be included
if the subject had up to 3 prior PDT treatments)

- Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0

- Previous participation in a clinical trial (for either eye) involving anti angiogenic
drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

- Previous subfoveal focal laser photocoagulation involving the foveal center in the
study eye

- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month
preceding Day 0

- History of vitrectomy, submacular surgery, or other surgical intervention for AMD in
the study eye

- Previous participation in any studies of investigational drugs within 1 month
preceding Day 0 (excluding vitamins and minerals)