Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced Fluence PDT With Visudyne in Patients With Exudative AMD

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barnes Retina Institute
• Collaborator: QLT Inc.
• Treatments: Ranibizumab; Verteporfin

Criteria

Inclusion Criteria:

• Ability to give informed consent

• Treatment- naïve patients with active, subfoveal, exudative AMD

• Patients with visual acuity of 20/40-20/320 in the study eye

• Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size

• The lesion must be < 5400microns in greatest linear dimension (GLD)

• Lesion size < 10 DA

• Occult with no classic CNV lesions must have presumed recent disease progression:

1. Blood associated with the lesion at baseline

2. Loss of visual acuity in the previous 3 months: a: > 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart

3. > 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months

• Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye

• Geographic atrophy or fibrosis in the study eye

• Intraocular surgery within 6 weeks of enrollment

• Subretinal hemorrhage > 50% of the total lesion

• Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications

• Patients with severe disciform scarring.

• Inability to make study visits

• Advanced glaucoma

• Allergies to porfins or a known hypersensitivity to any component of Visudyne®

• Patients with porphyria

• Pregnancy or lactation