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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967213
• Other study ID #: CBPD952AKR03
• Secondary ID: CCT-NAPN-18335
• Status: Completed
• Phase: Phase 3
• First received: August 26, 2009
• Last updated: August 26, 2009
• Start date: August 2006

Study information

• Verified date: August 2009
• Source: Novartis Korea Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Korea Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in ETDRS visual acuity letter scores from baseline.		every 4 weeks (up to 52 weeks)	No
Secondary	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)	Yes