Effects of Ranibizumab in Primary Pterygium Surgery
Condition: Patients With Primary Nasal Pterygium
MeSH terms: Pterygium
Study type: Interventional
Phase: Phase 1

Summary: 
      Pterygium is a common ocular surface disease in Malaysia. Without treatment, it can lead to
      severe visual impairment. Recurrence is the commonest complication and novel treatment
      approaches are crucial to prevent vision loss. The biological processes underlying the
      formation of pterygium are complex, but central to its pathogenesis is the angiogenic
      cytokine vascular endothelial growth factor (VEGF). VEGF is upregulated under conditions of
      increased oxidative stress, which plays an integral role in pterygium development
      (Cardenas-Cantu et al., 2016, Karaman, 2018, Norrby, 1998, Rossino et al., 2020, Shibunya,
      2011).Various biomarkers on pterygium have been identified and are useful to determine the
      effectiveness of new modality treatment for pterygium. These markers can be identified via
      histopathological stain such as Masson Trichrome to observe changes of collagen fibres. Other
      identifiable markers include the use of special immunohistochemical stain such as anti CD34
      antibody for microvascular density and anti-8-OHdG antibody for oxidative changes in the
      pterygium tissue. By analyzing the changes with or without Ranibizumab injection in addition
      to observation of clinical recurrence rate of pterygium, we are able to conclude the
      effectiveness of anti-VEGF on pterygium recurrence. The aim of the study was to evaluate the
      association between collagen fibres changes, microvascular density changes and inflammation
      resultant from oxidative stress with the clinical recurrence of pterygium following
      intralesional Ranibizumab injection in comparison to control group.
    

Detailed description: 
      This is a prospective interventional study conducted from May 2018 to April 2020. Patients
      with primary pterygium who attended eye clinic Hospital Universiti Sains Malaysia (HUSM)
      Kubang Kerian, Kelantan and fulfilled the inclusion and exclusion criteria were recruited as
      participants of this study. Convenient sampling method was applied for participants'
      recruitment where all patients will be given thorough explanation in regards to the study and
      subsequently divided into interventional and control group. Intervention group participants
      were given intralesional Ranibizumab (0.5mg/ 0.05mL) 2 weeks prior to pterygium excision
      surgery. Both groups of participants undergo pterygium excision with autologous conjunctival
      graft surgery thereafter. Excised pterygium tissues were sent to the laboratory for slide
      preparation and staining with specific reagents including Masson Trichrome for collagen
      fibers, anti CD34 antibody for microvascular density and anti-8 OHdG antibody for oxidative
      stress changes. Slides were then analysed by the pathologist and statistical analysis of the
      results were carried out with the Statistical Package for the Social Sciences (SPSS) Version
      26.0. All participants had intralesional Ranibizumab injection and pterygium excision with
      autologous conjunctival graft surgery in May 2018. They were scheduled for follow-up visits
      for the next 24 months to observe for complications of intralesional Ranibizumab injection,
      pterygium excision and conjunctival autograft surgery and any signs of recurrence.
    

Intervention name(s): intralesional ranibizumab
Intervention type(s): Biological
Intervention description(s): Lucentis; Genentech, Inc, San Francisco, California, USA 0.5mg/ 0.05mL
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment