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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title: Prospective Optical Coherence Tomography (OCT) Imaging of Patients With Neovascular AMD Treated With Intra-Ocular Ranibizumab (Lucentis) (PrONTO) Study

Status Completed

Clinical Trial 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.

Clinical Trial 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 least 300 µm as measured by optical coherence tomography (OCT) were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes were observed between visits: a loss of 5 letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new onset classic CNV, new macular hemorrhage, or persistent macular fluid following an injection of ranibizumab at the prior study visit. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

• NCT number: NCT00373659
• Study type: Interventional
• Source: University of Miami
• Status: Completed
• Phase: Phase 2
• Start date: August 2004
• Completion date: June 2007