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

Phase 3

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: ranibizumab

• Registration Number: NCT00967213
• Lead Sponsor: Novartis Korea Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2008-02
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	ranibizumab	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).

Primary Outcome Measures

Name	Time	Method
The change in ETDRS visual acuity letter scores from baseline.	every 4 weeks (up to 52 weeks)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu; 🇰🇷 Seoul, Korea, Republic of