Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration
Completed · Phase 1/Phase 2
Conditions studied: Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT00395707
- Run by
- The National Retina Institute
- People needed
- 20
- Starts
- 2005-08-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2009-02-09
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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)
Where it is running
- National Retina Institute — Chevy Chase, Maryland, United States
- National Retina Institute — Towson, Maryland, United States
Full record on ClinicalTrials.gov
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