Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
- Conditions
- Pathological Myopia
- Interventions
- Registration Number
- NCT01217944
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 277
- Visual impairment due to choroidal neovascularization (CNV) secondary to PM
- Best corrected visual acuity (BCVA) in the study eye > 24 and < 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters
- High myopia (> -6D), anterior-posterior elongation > 26 mm; posterior changes compatible with the pathologic myopia
- Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal
- Patients with uncontrolled systemic or ocular diseases
- Blood pressure > 150/90 mmHg
- History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye
- Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verteporfin PDT Sham verteporfin PDT Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed. Ranibizumab driven by disease activity Sham Ranibizumab Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria Verteporfin PDT Sham Ranibizumab Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed. Ranibizumab driven by stabilization criteria Sham Ranibizumab Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity Ranibizumab driven by stabilization criteria Sham verteporfin PDT Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity Verteporfin PDT Verteporfin PDT Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed. Ranibizumab driven by disease activity Sham verteporfin PDT Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria Ranibizumab driven by disease activity Ranibizumab Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria Ranibizumab driven by stabilization criteria Ranibizumab Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity Verteporfin PDT Ranibizumab Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
- Primary Outcome Measures
Name Time Method Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye Baseline, Month 1 through Month 3 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.
- Secondary Outcome Measures
Name Time Method Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye Baseline and Month 1 through Month 12 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
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 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.
Number of Ranibizumab Injections Received Prior to Month 3 Day 1 and prior to month 3 In order to describe exposure to the study drug the number of ejections was evaluated
Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye Baseline and Month 6 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.
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 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.
Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period Day 1 prior to month 6 and prior to month 12 Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 Months 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 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.
Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye Baseline and Month 12 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.
Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 Months 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.
Change From Baseline in Central Retinal Thickness of the Study Eye Over Time Baseline, Month 3, Month 6 and Month 12 Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.
Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period Month 3 up to month 12 Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧Wolverhampton, United Kingdom