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

NCT00967213 | Completed Phase 3

• 2 other identifiers: CBPD952AKR03CCT-NAPN-18335
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• The change in ETDRS visual acuity letter scores from baseline.

  every 4 weeks (up to 52 weeks)

Secondary Outcomes (1)

• 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)

Study Arms (1)

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).

Drug: ranibizumab

Interventions

ranibizumab DRUG

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).

Also known as: Lucentis

Ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Korea Ltd.: lead

Study Sites (1)

Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu

Seoul, 130-702, South Korea

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hyung-Woo Kwak

  Dept. of ophthalmology, KyungHee Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2009
• First Posted: August 27, 2009
• Study Start: August 1, 2006
• Primary Completion: February 1, 2008
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

KR (1)