Trial | NCT00967213  Report issue

Title

Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration
Changes in Preferential Hyperacuity Perimeter (PHP) and Fundus Autofluorescence (FAF) in Patients With Neovascular Age-related Macular Degeneration Receiving Combination of Ranibizumab and Verteporfin Therapy

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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
Study Started
Aug 31
2006
Primary Completion
Feb 29
2008
Last Update
Apr 22
2016
Estimate

Drug ranibizumab

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).

  • Other names: Lucentis

Ranibizumab Experimental

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).

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
No Results Posted