Immediate Effects of Lucentis® in Conjunction With Photodynamic Therapy With Visudyne® in Exudative AMD(IECOMB)

Age Related Macular Degeneration Clinical Trial

Official title: Open-label, Phase II Study Assessing Immediate Effects of Lucentis®(Ranibizumab) Administered in Conjunction With Photodynamic Therapy With Visudyne® in Patients With Choroidal Neovascularization Secondary to AMD

Status Completed

Clinical Trial Summary

This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.

Clinical Trial Description

The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.

A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab:

• on retinal thickness as measured by OCT over time

• in change of total lesion area, area of CNV assessed by FA

• in mean change of VA from baseline over time ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration

• NCT number: NCT00413829
• Study type: Interventional
• Source: University Hospital Inselspital, Berne
• Status: Completed
• Phase: Phase 2
• Start date: October 2006
• Completion date: March 2008