Clinical Trial: A Study of the Criteria Establishing the Need for Re-treatment With Ranibizumab Upon Relapse 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, Open-label, Interventional, Multicentre Study to Investigate the Current Criteria Driving Re-treatment With Ranibizumab Upon Relapse in Patients With Visual Impairment Due to

The primary objective of the study is to investigate current criteria driving re-treatment in patients affected by CNV secondary to PM and experiencing a relapse of the disease after the first administration of ranibizumab. The criteria for re-treatment may consist in patient subjectivity or a clinical decision (described through clinical examination, BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Descriptive statistic on the FAS population will be provided.

The proportion of patients who need re-treatment will be displayed together with a 95% confidence interval. The criteria for re-treatment will be summarized, presenting, for each, frequencies, percentages and 95% CI.



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual acuity changes [ Time Frame: baseline, month 6, month 12 ]
    To evaluate the mean changes in BCVA at 6M and 12M versus baseline. Summary statistics for BCVA will be provided for values at baseline and at each assessment and for changes versus baseline at each assessment. Results will be reported overall and separately for the sub-group of patients who need vs. not the re-treatment. A paired test of BCVA at 6 and 12 months vs. baseline will be also provided on all patients. An exploratory analysis of BCVA changes by class of disease duration, gender, age at entry, diopters and relevant medical conditions will be also provided.
  • mean number of ranibizumab injection [ Time Frame: baseline to month 12 ]
    To evaluate the mean number of ranibizumab injections by patient/year. The number and percentage of patients who need re-treatment will be provided.
  • time to relapse / retratment [ Time Frame: baseline to month 12 ]

    Time to re-treatment, defined as time in days from the data of first dose of ranibizumab to the date of re-treatment, will be evaluated. Descriptive statistics will be provided. A Kaplan-Meier curve will also be shown.

    The relationship between patient baseline characteristics and the need for re-treatment will be explored by means of logistic regression analysis

  • Number and percentage of patients having ocular or systemic adverse events [ Time Frame: baseline to month 12 ]

    AEs will be summarized as following: n° and % of patients having any AE, an ocular AE, a non-ocular AE, an AE in each primary system organ class, or with at least one serious ocular or non-ocular AE.

    Summary tables will be presented: overall and by gender, for the subset of AEs suspected to be treatment related.

    Deaths, SAEs, and AEs leading to discontinuation of investigational treatment will be listed separately and, if appropriate, summarized by primary system organ class and preferred term.

    IOP, vital signs measurements and laboratory data, where available, will be summarized with descriptive statistics of actual values and changes from baseline values. Summary tables will be presented overall and by gender.

    The incidence rates of notable vital sign abnormalities will be also provided.

  • Evaluation of patient quality of life [ Time Frame: baseline, month 2, month 12 ]

    To evaluate changes in the quality of life after ranibizumab injection, by means of IVI Questionnaire, a 32-item questionnaire developed to measure the impact of vision impairment on daily activities in five domains. Domain scores and total score will be summarized descriptively in actual values and changes versus baseline at each assessment.

    The Burden of Illness and Health Resources Utilization questionnaire will also be used ro gain information on resource consumption and burden for the patient and relatives to the disease. Summary statistic will be provided for each item.



Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: January 9, 2014
Date Started: June 10, 2014
Date Completion:
Last Updated: May 15, 2017
Last Verified: May 2017