Overview

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