CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
intralesional ranibizumabbiological
Likely dose
intralesional ranibizumab 0.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04878835
NCT04878835Phase 1Completed

Effects of Ranibizumab on Microvasculature, Oxidative Stress and Recurrence in Primary Pterygium Surgery

Universiti Sains Malaysia·interventional·Posted May 10, 2021·Updated May 10, 2021

In Brief

A Phase 1 clinical trial evaluating intralesional ranibizumab for Patients With Primary Nasal Pterygium. Completed, enrolled 52 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMalaysia
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 10, 2021
Enrollment StartMay 1, 2018
Primary CompletionApr 1, 2020
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.1 years ago

Interventions

intralesional ranibizumabbiological

Lucentis; Genentech, Inc, San Francisco, California, USA 0.5mg/ 0.05mL