Trial | NCT00395707  Report issue

Title

Study To Determine Safety/Efficacy of Lucentis For Treatment Of Retinal Angiomatous Proliferation Secondary To Age Related Macular Degeneration
Phase I Study Of Intravitreal Ranibizumab (Lucentis) For The Treatment Of Stage 1 And 2 Retinal Angiomatous Proliferations

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ranibizumab ...

  • Study Participants

    20
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.
This study will be a phase I/II open label interventional case series. Twenty patients with retinal angiomatous proliferation will be randomized to receive intravitreal ranibizumab at a dose of 0.3mg/0.05 ml or 0.5mg/0.05 ml. Patients will receive ranibizumab via a pars plana injection on a monthly basis for a total duration of therapy of 12 months. Patients will be followed for a complete 12-month treatment course.
Study Started
Aug 31
2005
Primary Completion
Apr 30
2008
Study Completion
Apr 30
2008
Last Update
Feb 09
2009
Estimate

Drug Lucentis

0.3mg/0.05 ml or 0.5mg/0.05 ml

  • Other names: Ranibizumab

Drug Ranibizumab

0.3mg/0.05 ml or 0.5mg/0.05 ml

  • Other names: Lucentis

Drug Ranibizumab (Lucentis)

0.3mg/0.05 ml intravitreally

  • Other names: Ranibizumab, Lucentis

Drug Ranibizumab (Lucentis)

0.5mg/0.05 ml

  • Other names: Ranibizumab, Lucentis

1 Active Comparator

Lucentis 0.3mg/0.05 ml

2 Active Comparator

Lucentis 0.5mg/0.05 ml

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)
No Results Posted