An OCT-Guided Variable Dosing Regimen With Ranibizumab for the Treatment of Neovascular AMD

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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 Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Ranibizumab (PrONTO) study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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