Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

Phase 3TerminatedNCT00433017

Novartis255 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

255

Conditions

Macular Degeneration Choroidal Neovascularization

Interventions

Verteporfin Photodynamic TherapyDRUG

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 to the study eye, begun 15 minutes after the start of the infusion.

RanibizumabDRUG

Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection

PlaceboDRUG

As a placebo for verteporfin photodynamic therapy (for masking purposes), 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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects of either gender age 50 years or older * Subfoveal choriodal neovascularization (CNV) due to age-related macular degeneration (AMD) Exclusion Criteria: * Choriodal neovascularization due to causes other than AMD * Prior treatment for neovascular AMD in the study eye Other protocol-defined inclusion/exclusion criteria may apply

Locations (12)

Novartis Investigative site

Vienna, Austria

Novartis Investigative site

Antwerp, Belgium

Novartis Investigative site

Aalborg, Denmark

Outcomes

Primary Outcomes

Change From Baseline in Best-corrected Visual Acuity (BCVA) at 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.

Time frame: Baseline and Month 12

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

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.

Time frame: Month 2 to Month 11

Secondary Outcomes

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

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

Time frame: Month 12

Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12

Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.

Time frame: Baseline and Month 12

Mean Change in Central Retinal Thickness of the Study Eye at Month 12

Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.

Time frame: Baseline and Month 12

Data from ClinicalTrials.gov

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