Clinical Trial: Efficacy and Safety of Ranibizumab 0.5 vs Veteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 12-month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Individualized Regimens of 0.5mg Ranibizumab vs. Verteporfin PDT in Pa

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 secondary to pathologic myopia (PM)

Detailed Summary:

This is a phase III, multi-center, randomized, double-masked, active-controlled study comparing 0.5 mg ranibizumab vs. vPDT therapy. The study includes 15 scheduled visits over 12 months, and there will be two additional visits (2a, 3a) for subset of patients in whom PK analysis will be performed.

There will be 3 periods in this study: Screening period-from Day -14 to Baseline; Treatment period-from Baseline to Month 11; Follow-up period-from Month 11 to Month 12 Patients will enter the 11 months Treatment period at Visit 2 (Day 1) if eligibility criteria are met and will be randomized in three treatment groups Group I ranibizumab 0.5 mg driven by VA stability criteria or Group II ranibizumab 0.5 mg driven by disease activity criteria or Group III vPDT (randomization ratio of 2:2:1) and will receive first treatment of either a ranibizumab injection and sham vPDT or sham injection and active vPDT and will return to the clinical center within 7 days to undergo safety assessments as well as assessments of the effect of treatment by the evaluating investigator. The following visits will be performed at one month intervals starting at Visit 4 and continuing through Visit 14.At all monthly visits (at/from Month 2 for group I, at/from Month 1 for group II and at/from Month 3 for group III) the decision for treatment will be made by the evaluating investigator based on the VA stability criteria and on the disease activity criteria. At Month 3 (visit 6) and at all following monthly visits for all three groups one of the three options can recommended by evaluating investigator: a) ranibizumab 0.5 mg, b) ranibizumab 0.5 mg + vPDT; c) vPDT. The treating investigator will then perform treatment based on randomization and masking requirements.

At each monthly visit, patients will have a safety evaluation by the evaluating investigator p
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: change from baseline BCVA to the average level of BCVA (letters) over all monthly post-baseline assessments: BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: Month 1 to Month 3 ]

Superior efficacy of 0.5 mg ranibizumab administered based on visual acuity stability criteria and/or disease activity re-treatment criteria compared to vPDT


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • average level of BCVA (letters); BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: Month 1 to Month 6 ]
    demonstrate non-inferiority of 0.5 mg ranibizumab intravitreal injections driven by disease activity re-treatment criteria versus 0.5 mg ranibizumab intravitreal injections driven by visual acuity stability criteria as assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from Month 1 to Month 6.
  • average level of BCVA (letters); BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: 12 months ]
    To compare the efficacy of the ranibizumab treatment groups as assessed by the change from baseline BCVA to the average level of BCVA over all monthly assessments from Month 1 to Month 12 and based on the time course of BCVA changes from baseline
  • Improvement in BCVA; BCVA score measured at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts [ Time Frame: 12 Months ]
    To compare BCVA improvement ≥10 and ≥15 letters or BCVA reaching 84 letters, and BCVA loss ≥10 and ≥15 letters for each month between treatment groups
  • Change in retinal thickness measured on OCT image by Reading center [ Time Frame: 12 Months ]
    To evaluate the time course of CRT/CSFT changes from baseline in the treatment groups
  • CNV leakage presence measured on Fluorescein angiography image by Reading center [ Time Frame: 12 Months ]
    To compare presence of active leakage over time up to Month 12 in the treatment groups
  • Quality of Life [ Time Frame: 12 Months ]
    To assess the impact on patient functioning and quality of life supported by ranibizumab 0.5 versus vPDT as assessed by the NEI-VFQ-25
  • Number of injections and period (time) between injections [ Time Frame: 12 months ]
    To assess treatment pattern with ranibizumab
  • Occurrence and incidence of the AEs [ Time Frame: 12 months ]
    To assess the safety and tolerability of 0.5 mg ranibizumab and vPDT


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: August 12, 2013
Date Started: September 11, 2013
Date Completion:
Last Updated: May 9, 2017
Last Verified: May 2017