Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 17 for:    novartis pdt lucentis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00436553
Recruitment Status : Completed
First Posted : February 19, 2007
Results First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Sponsor:
Information provided by:
Novartis

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Macular Degeneration Choroidal Neovascularization Drug: Verteporfin Photodynamic Therapy Drug: Ranibizumab Drug: Verteporfin Placebo Drug: Ranibizumab Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : February 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009


Arm Intervention/treatment
Experimental: 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.
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 (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 Name: Visudyne

Drug: Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
Other Name: Lucentis

Drug: 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.

Active Comparator: 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).
Drug: Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
Other Name: Lucentis

Drug: 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.

Experimental: 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.
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 (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 Name: Visudyne

Drug: Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
Other Name: Lucentis

Drug: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00436553


Locations
Hide Hide 43 study locations
Layout table for location information
United States, Arizona
Novartis Investigative Site
Tucson, Arizona, United States, 85704
United States, California
Novartis Investigative Site
Beverly Hills, California, United States, 90211
Novartis Investigative Site
Oakland, California, United States, 94609
Novartis Investigative Site
Pasadena, California, United States, 91105-3153
Novartis Investigative Site
Sacramento, California, United States, 95819
West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130
San Francisco, California, United States, 94107
Novartis Investigative Site
Santa Ana, California, United States, 92705
United States, Colorado
Novartis Investigative Site
Denver, Colorado, United States, 80210
United States, Hawaii
Novartis Investigative Site
Aiea, Hawaii, United States, 96701
United States, Iowa
Novartis Investigative Site
Iowa City, Iowa, United States, 52242
United States, Kansas
Novartis Investigative Site
Wichita, Kansas, United States, 67214
United States, Kentucky
Novartis Investigative Site
Lexington, Kentucky, United States, 40509
Novartis Investigative Site
Paducah, Kentucky, United States, 42001
United States, Maryland
Novartis Investigative Site
Baltimore, Maryland, United States, 21205
United States, Michigan
Novartis Investigative Site
Grand Rapids, Michigan, United States, 49252
Novartis Investigative SIte
Royal Oak, Michigan, United States, 48073
Novartis Investigative Site
Williamsburg, Michigan, United States, 49690
United States, Missouri
Novartis Investigative Site
Independence, Missouri, United States, 64055
Novartis Investigative Site
St. Louis, Missouri, United States, 63110
United States, New Jersey
Novartis Investigative Site
Toms River, New Jersey, United States, 08755
United States, New York
Novartis Investigative Site
Lynbrook, New York, United States, 11563
Novartis Investigative Site
Rochester, New York, United States, 14620
United States, Ohio
Novartis Investigative Site
Beachwood, Ohio, United States, 44122
Novartis Investigative Site
Cincinnati, Ohio, United States, 45242
Novartis Investigative Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States, 15213
Novartis Investigative Site
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
Novartis Investigative Site
West Columbia, South Carolina, United States, 29169
United States, South Dakota
Novartis Investigative Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Novartis Investigative Site
Kingsport, Tennessee, United States, 37660
Novartis Investigative Site
Knoxville, Tennessee, United States, 37909
United States, Texas
Novartis Investigative Site
Austin, Texas, United States, 78705
Novartis Investigative Site
Houston, Texas, United States, 77030
United States, Virginia
Novartis Investigative Site
Fairfax, Virginia, United States, 22031
Novartis Investigative Site
Richmond, Virginia, United States, 23226
United States, Wisconsin
Novartis Investigative Site
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada, T5H OX5
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada, V5Z 3N9
Canada, Nova Scotia
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y6
Canada, Ontario
Ivey Eye Institute, Dr. Thomas Sheidow
London, Ontario, Canada, N6A 4G5
Novartis Investigative Site
London, Ontario, Canada, N6A 4G5
Novartis Investigative Site
Ottawa, Ontario, Canada, KIH 8L6
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H2L 4MI
Sponsors and Collaborators
Novartis
Investigators
Layout table for investigator information
Study Chair: Novartis Novartis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00436553    
Other Study ID Numbers: CBPD952A2308
First Posted: February 19, 2007    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011
Last Verified: March 2011
Keywords provided by Novartis:
Age-related macular degeneration; AMD
choroidal neovascularization
verteporfin
ranibizumab
Additional relevant MeSH terms:
Layout table for MeSH terms
Ranibizumab
Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Verteporfin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents