Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF) in patients with neovascular age-related macular degeneration receiving combination of ranibizumab (LucentisTM) and verteporfin (Visudyne®) therapy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Korea Ltd.
• Treatments: Ranibizumab; Verteporfin

Criteria

Inclusion Criteria:

• Signed written informed consent

• Age ≥ 50 years old

• Patients with primary active subfoveal CNV secondary to AMD

• Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/40 to 20/400 using ETDRS chart

• Characteristics of AMD lesion

• predominantly or minimally classic, or occult

• absence of prior subfoveal treatment for macular disease

• total lesion size ≤ 9 optic disc areas, with CNV component ≥ 50% of the lesion (unless a serous pigment epithelial detachment was present, in which case < 50% CNV was acceptable)

• active choroidal neovascularization leakage

• submacular blood < 50% and subretinal fibrosis < 25% of the total lesion

Exclusion Criteria:

• additional eye disease that could compromise VA

• CNV unrelated to AMD

• ocular inflammation

• vitreous hemorrhage

• retinal hemorrhage (other than AMD related submacular blood) > 1 disc areas

• intraocular surgery ≤ 1 month before day 0

• uncontrolled glaucoma

• prior treatments with verteporfin PDT

• laser photocoagulation or other intervention for AMD

• previous treatment with external-beam radiation therapy or transpupillary thermotherapy

• history of vitrectomy