Clinical trial NCT00433017: Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Macular Degeneration
Choroidal Neovascularization
Keywords: Age-related macular degeneration
AMD
Choroidal neovascularization
Verteporfin
Ranibizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-09
Enrollment: 255
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.
timeFrame: Baseline and Month 12
measure: Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit
timeFrame: Month 2 to Month 11
Secondary outcomes:
measure: Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12
timeFrame: Month 12
measure: Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12
timeFrame: Baseline and Month 12
measure: Mean Change in Central Retinal Thickness of the Study Eye at Month 12
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Novartis Investigative site
city: Antwerpen
country: Belgium
facility: Novartis Investigative site
city: Aalborg
country: Denmark
facility: Novartis Investigative site
city: Creteil
country: France
facility: Novartis Investigative site
city: Regensburg
country: Germany
facility: Novartis Investigative site
city: Budapest
country: Hungary
facility: Novartis Investigative site
city: Firenze
country: Italy
facility: Novartis Investigative site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative site
city: Warszawa
country: Poland
facility: Novartis Investigative site
city: Madrid
country: Spain
facility: Novartis Investigative site
city: Geneve
country: Switzerland
facility: Novartis Investigative site
city: Manchester
country: United Kingdom
facility: Novartis Investigative site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Ritter M, Simader C, Bolz M, Deak GG, Mayr-Sponer U, Sayegh R, Kundi M, Schmidt-Erfurth UM. Intraretinal cysts are the most relevant prognostic biomarker in neovascular age-related macular degeneration independent of the therapeutic strategy. Br J Ophthalmol. 2014 Dec;98(12):1629-35. doi: 10.1136/bjophthalmol-2014-305186. Epub 2014 Jul 30.
citation: 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.