Phase 4
N=61
Efficacy and Safety of Verteporfin Added to Ranibizumab in the Treatment of Symptomatic Macular Polypoidal Choroidal Vasculopathy
Polypoidal Choroidal Vasculopathy
Bottom Line
View on ClinicalTrials.gov: NCT00674323 ↗Enrolled (actual)
61
Serious AEs
6.6%
Results posted
Jan 2011
Primary outcome: Primary: Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA) — 14; 15; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Verteporfin Photodynamic Therapy (Drug); Ranibizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Regression (CR) of Polyps Measured by Indocyanine Green Angiography (ICGA) |
14; 15; 6 | — |
| SECONDARY Number of Participants With at Least One Complete Polyp Regression During 6 Months Assessed by ICGA |
15; 18; 9 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness Measured by Optic Coherence Tomography (OCT) |
324.1; 285.3; 268.5; -145.6; -98.1; -65.7 | — |
| SECONDARY Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 6 |
59.8; 57.2; 49.0; 10.9; 7.5; 9.2 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00674323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.