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

Status unconfirmed · Not applicable

Conditions studied: Age-Related Macular Degeneration

In brief

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

Key facts

Study ID

NCT00455871

Run by

Barnes Retina Institute

People needed

30

Starts

2007-04-01

Expected to finish

2010-10-01

Last updated by the study team

2008-05-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Blood associated with the lesion at baseline
• 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
• > 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

Where it is running

• Barnes Retina Institute — St Louis, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

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