Effects of Ranibizumab in Primary Pterygium Surgery

Sponsor
Universiti Sains Malaysia
Study ID
NCT04878835
Phase
PHASE1
Status
Completed

Conditions

  • Patients With Primary Nasal Pterygium

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
May 10, 2021
Start date
May 1, 2018
Status verified
May 2021
Primary completion
Apr 1, 2020
Completion
Apr 30, 2020

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control group
    No intervention was given. No intralesional ranibizumab (Lucentis; Genentech, Inc, San Francisco, California, USA 0.5mg/ 0.05mL) was given at 2 weeks prior to pterygium excision surgery
  • Experimental: Intervention group
    The interventional group was given intralesional ranibizumab (Lucentis; Genentech, Inc, San Francisco, California, USA 0.5mg/ 0.05mL) 2 weeks prior to pterygium excision surgery

Primary Outcome Measure

Microvascular Density (MVD) using anti-CD34 antibody staining, classified based on the Weidner scoring system. [ Time Frame: After pterygium excision surgery, tissues were sent to the histopathological laboratory where microvascular density was assessed within two weeks ]