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

Polypoidal Choroidal Vasculopathy Clinical Trial

— PCV  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674323
• Other study ID #: CBPD952A2209
• Status: Completed
• Phase: Phase 4
• First received: May 5, 2008
• Last updated: April 15, 2011
• Start date: April 2008

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

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.
• Ranibizumab
Ranibizumab at dose of 0.5 mg administered as an intravitreal injection.

Locations

Country	Name	City	State
Hong Kong	Novartis Investigative Site	Hong Kong
Korea, Republic of	Novartis Investigative Site	Seoul
Singapore	Novartis Investigative Site	Singapore
Taiwan	Novartis Investigative Site	Taipei
Thailand	Novartis Investigative Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Hong Kong,  Korea, Republic of,  Singapore,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA)	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.	Month 6	No
Secondary	Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA	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.	Baseline through end of study (6 months)	No
Secondary	Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT)	High resolution 6 meridian scans were performed to measure central retinal thickness.	Baseline and Month 6	No
Secondary	Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6	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.	Baseline and Month 6	No