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NCT01217944 Clinical Trial

Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Pathological Myopia Clinical Trial

Official title:
A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01217944
Other study ID # CRFB002F2301
Secondary ID 2010-021662-30
Status Completed
Phase Phase 3
First received October 6, 2010
Last updated January 14, 2014
Start date October 2010
Est. completion date August 2012
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Clinical Trial 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).

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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ranibizumab
0.5 mg ranibizumab intravitreal injection
• Verteporfin PDT
Verteporfin (6 mg/m2) intravenous infusion
• Sham Ranibizumab
Empty vial to mimic the intravitreal injection
• Sham verteporfin PDT
Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
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Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Canada,  France,  Germany,  Hong Kong,  Hungary,  India,  Italy,  Japan,  Korea, Republic of,  Latvia,  Lithuania,  Poland,  Portugal,  Singapore,  Slovakia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline, Month 1 through Month 3 No
Secondary 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. Baseline and Month 6 No
Secondary 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 Baseline and Month 1 through Month 12 No
Secondary 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. Month 3 No
Secondary 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. Months 6 and 12 No
Secondary 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. Month 3 No
Secondary 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. Months 6 and 12 No
Secondary 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. Baseline, Month 3, Month 6 and Month 12 No
Secondary 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. Baseline and Month 12 No
Secondary Number of Ranibizumab Injections Received Prior to Month 3 In order to describe exposure to the study drug the number of ejections was evaluated Day 1 and prior to month 3 Yes
Secondary 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 Day 1 prior to month 6 and prior to month 12 Yes
Secondary 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. Month 3 up to month 12 Yes
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Recruiting NCT03128463 - Pharmacogenomic Study on Anti-VEGF Medicine in Treatment of Macular Neovascular Diseases N/A
Recruiting NCT00155753 - Genomewide Screening of Pathological Myopia N/A