Status:
COMPLETED
An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD
Lead Sponsor:
University of Miami
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
This study was designed to evaluate a variable dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD) in the Prospective OCT...
Detailed Description
In this 2-year open-label, prospective, single-center, uncontrolled, investigator sponsored clinical study, neovascular AMD patients with subfoveal CNV (N=40) and a central retinal thickness of at lea...
Eligibility Criteria
Inclusion
- Age 50 years or older
- Active primary or recurrent macular neovascularization secondary to age-related macular degeneration (AMD) involving the central fovea in the study eye with evidence of disease progression
- OCT central retinal thickness ≥ 300 microns
- Best corrected visual acuity, using ETDRS charts, of 20/40 to 20/400 (Snellen equivalent) in the study eye
Exclusion
- More than 3 prior treatments with verteporfin photodynamic therapy
- Previous participation in a clinical trial (for either eye) involving antiangiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors)
- Previous subfoveal focal laser photocoagulation in the study eye
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding day 0
- Subfoveal fibrosis or atrophy in the study eye
- History of vitrectomy surgery in the study eye
- Aphakia or absence of the posterior capsule in the study eye
- History of idiopathic or autoimmune-associated uveitis in either eye
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00373659
Start Date
August 1 2004
End Date
June 1 2007
Last Update
June 13 2012
Active Locations (1)
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1
Bascom Palmer Eye Instiyute
Miami, Florida, United States, 33136