Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
NCT ID: NCT00436553
Last Updated: 2011-04-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
321 participants
INTERVENTIONAL
2007-02-28
2009-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
NCT00433017
Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)
NCT01846273
Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration
NCT00288561
Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
NCT01922102
Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration
NCT00967213
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Verteporfin With Standard Fluence Rate Plus Ranibizumab
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate 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 choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
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 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
Ranibizumab Placebo
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.
Ranibizumab Monotherapy
Patients received monthly ranibizumab injections for 12 months and thereafter as needed 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. 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 choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
Verteporfin Placebo
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.
Verteporfin With Reduced Fluence Rate Plus Ranibizumab
Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate 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 choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
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 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
Ranibizumab Placebo
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 (Standard Fluence rate) or 25 J/cm\^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
Verteporfin Placebo
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
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)
Exclusion Criteria
* Prior treatment for neovascular AMD in the study eye
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Novartis
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis
Role: STUDY_CHAIR
Novartis
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Beverly Hills, California, United States
Novartis Investigative Site
Oakland, California, United States
Novartis Investigative Site
Pasadena, California, United States
Novartis Investigative Site
Sacramento, California, United States
West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130
San Francisco, California, United States
Novartis Investigative Site
Santa Ana, California, United States
Novartis Investigative Site
Denver, Colorado, United States
Novartis Investigative Site
‘Aiea, Hawaii, United States
Novartis Investigative Site
Iowa City, Iowa, United States
Novartis Investigative Site
Wichita, Kansas, United States
Novartis Investigative Site
Lexington, Kentucky, United States
Novartis Investigative Site
Paducah, Kentucky, United States
Novartis Investigative Site
Baltimore, Maryland, United States
Novartis Investigative Site
Grand Rapids, Michigan, United States
Novartis Investigative SIte
Royal Oak, Michigan, United States
Novartis Investigative Site
Williamsburg, Michigan, United States
Novartis Investigative Site
Independence, Missouri, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
Toms River, New Jersey, United States
Novartis Investigative Site
Lynbrook, New York, United States
Novartis Investigative Site
Rochester, New York, United States
Novartis Investigative Site
Beachwood, Ohio, United States
Novartis Investigative Site
Cincinnati, Ohio, United States
Novartis Investigative Site
Cleveland, Ohio, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
West Mifflin, Pennsylvania, United States
Novartis Investigative Site
West Columbia, South Carolina, United States
Novartis Investigative Site
Rapid City, South Dakota, United States
Novartis Investigative Site
Kingsport, Tennessee, United States
Novartis Investigative Site
Knoxville, Tennessee, United States
Novartis Investigative Site
Austin, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Fairfax, Virginia, United States
Novartis Investigative Site
Richmond, Virginia, United States
Novartis Investigative Site
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Halifax, Nova Scotia, Canada
Ivey Eye Institute, Dr. Thomas Sheidow
London, Ontario, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kaiser PK, Boyer DS, Cruess AF, Slakter JS, Pilz S, Weisberger A; DENALI Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month results of the DENALI study. Ophthalmology. 2012 May;119(5):1001-10. doi: 10.1016/j.ophtha.2012.02.003. Epub 2012 Mar 22.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CBPD952A2308
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.