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Completed

NCT Number: NCT02342392

Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study

The purpose of this study is to evaluate the pterygium vascularity and size before and after intralesional ranibizumab injection and to evaluate its recurrence rate following pterygium excision surgery.

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Key information

Conditions

Pterygium Conjunctival Diseases Disease Attributes Eye Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

The purpose of this study is to:

  • Compare the vascularity of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
  • Compare the size of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
  • Compare the recurrence rate at 1 year after pterygium excision surgery between the group with and without intralesional ranibizumab injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients with primary pterygium.
  • Grade T3 (fleshy) pterygium.

Exclusion criteria

  • Patients with other ocular surface disorders.
  • Previous ocular surgery or trauma.
  • History of systemic thromboembolic event.
  • Pregnant women and lactating mother.

Treatment and study plan

ranibizumab

Drug

Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.

Other names: Lucentis

Primary outcomes

  1. pterygium recurrence

    Time frame: 1 year

    pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)

Secondary outcomes

  1. pterygium vessel area

    Time frame: 1 week

    Pterygium vesel area is defined as the as the ration of pixels occupied by the vessels within the pterygium area in percentage.

  2. corneal pterygium area

    Time frame: 1 week

    Corneal pterygium area is defined as the as the ration of pixels occupied by the pterygium within the cornea area in percentage.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 19, 2015
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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