Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration
NCT ID: NCT00395707
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2005-08-31
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Lucentis 0.3mg/0.05 ml
Lucentis
0.3mg/0.05 ml or 0.5mg/0.05 ml
Ranibizumab
0.3mg/0.05 ml or 0.5mg/0.05 ml
Ranibizumab (Lucentis)
0.3mg/0.05 ml intravitreally
2
Lucentis 0.5mg/0.05 ml
Lucentis
0.3mg/0.05 ml or 0.5mg/0.05 ml
Ranibizumab
0.3mg/0.05 ml or 0.5mg/0.05 ml
Ranibizumab (Lucentis)
0.5mg/0.05 ml
Interventions
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Lucentis
0.3mg/0.05 ml or 0.5mg/0.05 ml
Ranibizumab
0.3mg/0.05 ml or 0.5mg/0.05 ml
Ranibizumab (Lucentis)
0.3mg/0.05 ml intravitreally
Ranibizumab (Lucentis)
0.5mg/0.05 ml
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
ALL
Yes
Sponsors
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Genentech, Inc.
INDUSTRY
The National Retina Institute
OTHER
Responsible Party
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National Retina Institute
Principal Investigators
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Thomas M Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
National Retina Institute
Locations
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National Retina Institute
Chevy Chase, Maryland, United States
National Retina Institute
Towson, Maryland, United States
Countries
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Other Identifiers
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FVF3423s
Identifier Type: -
Identifier Source: org_study_id
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