Status:
COMPLETED
Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy
Lead Sponsor:
Novartis
Conditions:
Polypoidal Choroidal Vasculopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 po...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00674323
Start Date
April 1 2008
Last Update
April 19 2011
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Hong Kong, Hong Kong
2
Novartis Investigative Site
Singapore, Singapore
3
Novartis Investigative Site
Seoul, South Korea
4
Novartis Investigative Site
Taipei, Taiwan