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OpenTrials
Completed

NCT Number: NCT00967213

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

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

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Seoul, 130-702, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Lucentis

Primary outcomes

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

    Time frame: 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

    Time frame: every 4 weeks (up to 52 weeks)

Sponsors and collaborators

Lead sponsor

Novartis Korea Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
First posted
Aug 27, 2009
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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