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Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Information source: Ramathibodi Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pterygium of the Conjunctiva and Cornea

Intervention: Fluorometholone (Drug); Bevacizumab (Drug); Bevacizumab (Drug); Bevacizumab (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ramathibodi Hospital

Official(s) and/or principal investigator(s):
Kaevalin Lekhanont, MD, Principal Investigator, Affiliation: Ramathibodi Hospital

Summary

Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.

Clinical Details

Official title: A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Severity of impending recurrent pterygium

Secondary outcome:

Visual analog scales

Adverse reactions

Detailed description: 1. Impending recurrent pterygium 2. Anti-VEGF therapy

- Bevacizumab

- Subconjunctival injection

- Suppress neovascularization

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting. 2. Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment. 3. No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation. 4. No other ocular surface pathologies or coexisting ocular diseases. 5. No other ocular surgeries within the previous 6 months. 6. No history of allergy to the medications used in this study. 7. Good compliance with the study regimen and availability for the duration of the entire study period. Exclusion Criteria: 1. Platelet disorders 2. Hypertension 3. Pregnant or lactating women

Locations and Contacts

Ramathibodi Hospital, Bangkok 10400, Thailand
Additional Information

Starting date: January 2008
Last updated: February 1, 2011

Page last updated: August 20, 2015

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