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OpenTrials
Completed

NCT Number: NCT00436553

Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

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Key information

Conditions

Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects of either gender age 50 years or older
  • Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)

Exclusion criteria

  • Choroidal neovascularization due to causes other than AMD
  • Prior treatment for neovascular AMD in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Verteporfin photodynamic therapy

Drug

After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 (Standard Fluence rate) or 25 J/cm^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.

Other names: Visudyne

ranibizumab

Drug

Ranibizumab 0.5 mg administered as an intravitreal injection.

Other names: Lucentis

Verteporfin Placebo

Drug

To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.

Ranibizumab Placebo

Drug

To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.

Primary outcomes

  1. Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12

    Time frame: Baseline and Month 12

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.

  2. Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit

    Time frame: Month 2 up to Month 11

    The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.

Secondary outcomes

  1. Change From Baseline in Total Area of Leakage of the Study Eye at Month 12

    Time frame: Baseline and Month 12

    Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).

  2. Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12

    Time frame: Month 12

    The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).

  3. Change From Baseline in Central Retinal Thickness at Month 12

    Time frame: Baseline and Month 12

    Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Feb 19, 2007
Registry last updated
Apr 19, 2011

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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