Neovascular Age-related Macular Degeneration
Conditions
Brief 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
Interventions
DRUGranibizumab
Lucentis® (ranibizumab) 0.3mg (0.05ml volume) intravitreal injection. Eligible patients will be initially received three session of monthly injection of Lucentis® (week 0, 4, 8). After 4 weeks from third injection, a session of verteporfin PDT (week 12) and fourth injection of Lucentis® (week 16) will be added at intervals of 4 weeks. Two more combined treatment with verteporfin PDT and Lucentis® injection 4 weeks apart can be added at the treating physician's discretion in 3-month intervals (week 28, week 40).
Sponsors
Novartis Korea Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in ETDRS visual acuity letter scores from baseline. | every 4 weeks (up to 52 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Effect on CNV and RPE using preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF). Retinal thickness using optical coherence tomography (OCT). Recurrence of fluorescein leakage. The need for additional PDT treatment | every 4 weeks (up to 52 weeks) |
Countries
South Korea
Outcome results
None listed