Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the effect of Visudyne® combination therapy (Visudyne® [verteporfin for injection] and Lucentis™) on visual acuity outcomes. Study results will be submitted for publication to provide data that may help physicians refine the clinical management of patients with CNV secondary to age-related macular degeneration (AMD).

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

Details

• Lead Sponsor: Fondazione G.B. Bietti, IRCCS
• Treatments: Ranibizumab; Verteporfin

Criteria

Inclusion Criteria:

• 50 years or older male or female patients of any race with subfoveal CNV secondary to AMD (all types of lesion).

• The total area of CNV encompassed within the lesion must be >50% of the total lesion area. The total lesion area must have the greatest linear dimension ≤5400 microns (9 MPS Disc Areas).

• BCVA letter score in the study eye should be between 73 and 24 (approximately 20/40 to 20/320 Snellen Equivalent) using an ETDRS chart measured at 4 meters distance.

Exclusion Criteria:

• Any prior treatments with Visudyne, Macugen, Lucentis (Ranibizumab), Avastin (Bevacizumab) or other anti-angiogenic or corticosteroid intravitreal treatment in the study eye

• Prior external-beam radiation, subfoveal focal laser photocoagulation, transpupillary thermotherapy, pars plana vitrectomy in the study eye

• History of intraocular surgery in the study eye except for uncomplicated cataract surgery more than 90 days prior to treatment

• History of YAG-laser posterior capsulotomy in the study eye within 30 days prior treatment

• Use of non steroid antinflammatory drugs during the study

• Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (>8 D)

• Presence of fibrosis, haemorrhage, pigment epithelial detachments or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion

• Tear (rip) of the retinal pigment epithelium

• Vitreal haemorrhage, retinal detachment or macular hole

• Epiretinal membrane

• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with two or more topical pharmacological antiglaucomatous medication)

• Active or history of ocular inflammation or infection

• Aphakia and posterior capsule tear

• Pregnant or nursing (lactating) women

• Women of child-bearing potential unless they meet the following definition of postmenopausal

• Any systemic medical condition that may interferes with the safety of the patient

• Positive anamnesis for tumor in last the 5 years