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

This study has been terminated.
(Study was terminated based on the results of analyses performed as planned at Month 12.)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00433017
First received: February 8, 2007
Last updated: April 18, 2011
Last verified: April 2011

February 8, 2007
April 18, 2011
May 2007
July 2009   (final data collection date for primary outcome measure)
  • Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12. [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.
  • Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit [ Time Frame: Month 2 to Month 11 ] [ Designated as safety issue: No ]
    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.
  • Change from baseline in best-corrected visual acuity (BCVA) (letters) at Month 12.
  • Treatment-free interval of at least 3 months duration following Month 2
Complete list of historical versions of study NCT00433017 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
  • Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.
  • Mean Change in Central Retinal Thickness of the Study Eye at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.
  • Retreatment pattern of combination therapy based on the time to first retreatment, the number of retreatments
  • Safety of combination therapy and monotherapy over 12 months
  • Changes in Best Corrected Visual Acuity from baseline over 12 months
  • Angiographic and optical coherence tomography (OCT) outcomes from baseline over 12 months
  • Onset of effect assessed by change from baseline in BCVA at Months 1, 2 and 3
Not Provided
Not Provided
 
Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
24-month Randomized, Double-masked, Controlled, Multicenter, Phase II 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 AMD.

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Macular Degeneration
  • Choroidal Neovascularization
  • Drug: Verteporfin Photodynamic Therapy
    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.
    Other Name: Visudyne
  • Drug: Ranibizumab
    Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection
    Other Name: Lucentis
  • Drug: Placebo
    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.
  • Experimental: Verteporfin + Ranibizumab
    Verteporfin (6 mg/m^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
    Interventions:
    • Drug: Verteporfin Photodynamic Therapy
    • Drug: Ranibizumab
  • Active Comparator: Ranibizumab Monotherapy
    Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
    Interventions:
    • Drug: Ranibizumab
    • Drug: Placebo
Larsen M, Schmidt-Erfurth U, Lanzetta P, Wolf S, Simader C, Tokaji E, Pilz S, Weisberger A; MONT BLANC Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. Ophthalmology. 2012 May;119(5):992-1000. doi: 10.1016/j.ophtha.2012.02.002. Epub 2012 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
255
July 2009
July 2009   (final data collection date for primary outcome measure)

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

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT00433017
CBPD952A2309
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP