Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV)

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00674323
First received: May 5, 2008
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

This study aims to compare the efficacy of ranibizumab and verteporfin PDT combination treatment and verteporfin PDT monotherapy vs.ranibizumab monotherapy alone in achieving complete regression of polyps in patients with symptomatic macular polypoidal choroidal vasculopathy.


Condition Intervention Phase
Polypoidal Choroidal Vasculopathy
Drug: Verteporfin Photodynamic Therapy
Drug: Ranibizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double Masked, Exploratory, Indocyanine Green Angiography (ICGA) Guided Study of 6 Months Duration to Compare the Safety and Effect on Polyp Regression of Verteporfin Photodynamic Therapy (PDT) Alone or Added to Ranibizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA) [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.


Secondary Outcome Measures:
  • Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA [ Time Frame: Baseline through end of study (6 months) ] [ Designated as safety issue: No ]
    Indocyanine green angiography (ICGA) assessments were performed using the Heidelberg Retinal Angiography 2 (HRA2) machine to measure the Total Lesion Area and the degree of polyp regression. Complete regression was defined as no polyps seen on the imaging.

  • Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]
    High resolution 6 meridian scans were performed to measure central retinal thickness.

  • Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6 [ Time Frame: Baseline and Month 6 ] [ 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.


Enrollment: 61
Study Start Date: April 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verteporfin and Ranibizumab
Photodynamic therapy with verteporfin in combination with ranibizumab injection. Patients received one treatment at baseline with verteporfin photodynamic therapy (PDT) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
Drug: Verteporfin Photodynamic Therapy
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, light application of 50 J/cm^2 to the study eye was begun 15 minutes after the start of infusion.
Other Name: Visudyne
Drug: Ranibizumab
Ranibizumab at dose of 0.5 mg administered as an intravitreal injection.
Other Name: Lucentis
Active Comparator: Verteporfin monotherapy
Patients received one treatment at baseline with verteporfin photodynamic therapy in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab placebo (sham intravitreal injection) on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
Drug: Verteporfin Photodynamic Therapy
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, light application of 50 J/cm^2 to the study eye was begun 15 minutes after the start of infusion.
Other Name: Visudyne
Active Comparator: Ranibizumab monotherapy
Patients received one treatment at baseline with verteporfin placebo (with sham photodynamic therapy) in the study eye and thereafter based on re-treatment criteria at intervals of at least 90 days. Within 1-24 hours, patients also received Ranibizumab intravitreal injection on Day 1 and at Month 1 and 2 and thereafter according to the re-treatment criteria at intervals of at least 30 days through Day 150. From month 3 onward, re-treatments were determined based on study-specific re-treatment criteria that included evaluation of polyp progression on indocyanine green angiography (ICGA), and assessment of fluorescein angiograms and visual acuity.
Drug: Ranibizumab
Ranibizumab at dose of 0.5 mg administered as an intravitreal injection.
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must give written informed consent before any assessment is performed.
  • Male or Female patients ≥18 yrs of age
  • Patients willing and able to comply with all study procedures

Inclusion criteria for study eye:

  • BCVA letter score between 73-24 (approximately 20/40 to 20/320 Snellen equivalent) using ETDRS visual acuity chart measured at 4 meters
  • PCV diagnosis confirmed by Central Reading Center
  • Greatest Linear Dimension (GLD) of the total lesion area < 5400 µm (~9 Macular Photocoagulation Study Disc Areas)

Exclusion Criteria:

  • Women of child-bearing potential who are not using one or more reliable contraception methods
  • Pregnant or nursing (lactating) women
  • History of hypersensitivity or allergy to fluorescein or indocyanine green (ICG), clinically significant drug allergy or known hypersensitivity to therapeutic or diagnostic protein products, or to any of the study drugs or their components
  • Patient with history of porphyria
  • Systemic medications known to be toxic to the lens, retina, or optic nerve
  • History of which might affect the interpretation of the results of the study, or renders the patient at high risk from treatment complications
  • Use of other investigational drugs within 30 days of randomization

Exclusion criteria for study eye:

  • Concomitant conditions/diseases:
  • Presence of angioid streaks, macular fibrosis, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 Diopters or more)
  • Active ocular inflammation or infection
  • Uncontrolled glaucoma
  • Ocular disorders that may confound interpretation of study results

Prior Ocular treatment:

  • Prior Verteporfin PDT, external-beam radiation, laser photocoagulation, macular surgery, or transpupillary thermotherapy
  • Prior local treatment with Pegaptanib, Ranibizumab, Bevacizumab or other anti-angiogenic compound or any investigational treatment in both eyes or systemic use of bevacizumab within 90 days prior to randomization
  • History of intraocular surgery including pars plana vitrectomy and intraocular hemorrhage displacement is not allowed with the exception of uncomplicated cataract surgery that is allowed within 60 days prior to screening
  • Ocular conditions that required chronic concomitant therapy within 90 days prior to randomization with topical, ocular, or systemically administered corticosteroids or any herbal medication known to contain steroid-like components

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674323

Locations
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of
Singapore
Novartis Investigative Site
Singapore, Singapore
Taiwan
Novartis Investigative Site
Taipei, Taiwan
Thailand
Novartis Investigative Site
Bangkok, Thailand
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00674323     History of Changes
Other Study ID Numbers: CBPD952A2209
Study First Received: May 5, 2008
Results First Received: December 21, 2010
Last Updated: April 15, 2011
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Novartis:
Polypoidal choroidal vasculopathy
PCV
Age-related macular degeneration (AMD) variant
vision
polyps
indocyanine green angiography
verteporfin
ranibizumab
photodynamic therapy

Additional relevant MeSH terms:
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014