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

Novartis

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: ranibizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00967213

CBPD952AKR03

CCT-NAPN-18335

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Ranibizumab

Experimental group

Description:

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).

Treatment:

Drug: ranibizumab