This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
277
0.5 mg ranibizumab intravitreal injection
Verteporfin (6 mg/m2) intravenous infusion
Empty vial to mimic the intravitreal injection
Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye
The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.
Time frame: Baseline, Month 1 through Month 3
Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye
The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.
Time frame: Baseline and Month 6
Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye
The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12
Time frame: Baseline and Month 1 through Month 12
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3
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 increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.
Time frame: Month 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
Novartis Investigative Site
Vienna, Austria, Austria
Novartis Investigative Site
Linz, Upper Austria, Austria
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Bordeaux, France, France
Novartis Investigative Site
Dijon, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Reims, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Berlin, Germany
...and 64 more locations
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 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 increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.
Time frame: Months 6 and 12
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3
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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.
Time frame: Month 3
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.
Time frame: Months 6 and 12
Change From Baseline in Central Retinal Thickness of the Study Eye Over Time
Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.
Time frame: Baseline, Month 3, Month 6 and Month 12
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye
CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.
Time frame: Baseline and Month 12
Number of Ranibizumab Injections Received Prior to Month 3
In order to describe exposure to the study drug the number of ejections was evaluated
Time frame: Day 1 and prior to month 3
Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period
Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period
Time frame: Day 1 prior to month 6 and prior to month 12
Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period
Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.
Time frame: Month 3 up to month 12