A 36 month observational study to describe the long-term efficacy and safety of ranibizumab 0.5 mg treatment in patients with visual impairment due to choroidalneovascularization (CNV) secondary to pathologic myopia (PM)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, multicenter, open label study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RANIBIZUMAB
• Medical condition to be studied:
  Pathologic myopia

Population studied

• Short description of the study population:
  300 male or female patients diagnosed with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and intended to be treated with ranibizumab were planned to be entered into the study and to be observed for a period of 36 months.; In order to be included into the study, patients had to meet the following selection criteria:; 1. be willing and able to sign an Informed Consent; 2. be diagnosed with visual impairment due to CNV secondary to PM and be intended to be treated with ranibizumab; 3. be ≥ 18 years old (adults per local regulations); 4. has not been treated with a systemic VEGF inhibitor for 90 days prior to enrollment; 5. has not been treated with an ocular VEGF inhibitor for 30 days prior to enrollment, or intravitreal/subTenons steroids for 90 days prior to enrollment ; Pregnant women were not allowed to be included except if, in the opinion of the investigator, the expected benefit outweighted the potential risk to the fetus. Women of childbearing potential had to use an effective method of contraception. Breast-feeding was not recommended during the use of ranibizumab. The patient could have received previous treatment for CNV secondary to PM (e.g, vPDT, laser, anti-VGEF including ranibizumab).
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Pathologic myopia patients
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  To describe the long-term efficacy of ranibizumab as it is used in routine clinical practice for the treatment of visual impairment due to CNV secondary to PM. This will be determined by assessing the change in best corrected visual acuity (BCVA) from study entry throughout a 36 month observational period, in the primary eye designated for treatment.
• Outcomes:
  Change in best corrected visual acuity (BCVA) from study entry throughout a 36 month observational period, in the primary eye designated for treatment. 1 Ocular and systemic safety of ranibizumab 0.5 mg.2 Categorized change in BCVA over time, from study entry to month 36. 3 Efficacy by lesion subtype 4 Visual acuity outcomes in patients previously treated with vPDT or laser treatment.5 Visual acuity outcomes and safety in patients receiving combined treatment of vPDT and ranibizumab.
• Data analysis plan:
  No hypotheses are planned to be testing for this single arm observational study. Descriptive statistics and time plots will be used to describe the change from baseline in BCVA throughout the trial. If there are sufficient data, subgroup analyses will be conducted to explore differences amongst patients receiving different treatments (separately for before and during the trial). Safety will be explored using treatment emerging adverse events.

Documents

Study results

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