Strategies for Management of Recurrent Pterygium

NCT02530801 | Unknown Phase 4

• 1 other identifier: 15073
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pterygium is a common eye disease. Its mechanism remains unknown but studies suggest that it is related to exposure to ultraviolet rays and ocular dryness. Pterygium affects vision by causing astigmatism and may encroach on cornea (transparent part of the eye) affecting vision. It could cause ocular irritation and can be cosmetically unacceptable especially when inflamed. Recurrence is the most common outcome of pterygium excision. Recurrence rates of pterygium vary from 10 to more than 80%. Recurrence can be detected first in the conjunctiva(skin of your eye), before advancing on to the cornea. Treating the recurrent pterygium before the cornea gets involved avoids repeat surgery, which is difficult and is associated with more scarring. To avoid repeated surgeries, the activity of a recurrent pterygium should be stopped before it progresses to true recurrence. Several studies attributed the recurrence pf pterygium to the increase of substances as vascular endothelial growth factor(VEGF) and fibroblast growth factor. Avastin (Anti-VEGF) and 5 fluorouracil(5FU) (antimetabolite) are medications that suppress the formation of VEGF and fibroblast growth factor. Studies have shown that the subconjunctival injection of 5 F and Avastin into the recurring pterygium has been both safe and effective in treatment of recurrent pterygium. In many cases, vascularization and inflammation were controlled by subconjunctival Avastin, providing evidence for a role of VEGF in pterygium formation. 5FU is widely used in ophthalmology because of its anti-scarring properties. The other option for treatment of recurrent pterygium is surgery. Recurrent pterygium is a challenging condition that usually resists conventional surgery and its rate of recurrence after surgery is high. Moreover, recurrent pterygium surgery is usually accompanied by scarring, more risk of intra and post- complications This study aims to generate data to inform further studies towards establishing Avastin and 5 fluouracil as treatment modality for recurrent pterygium.

Conditions

Recurrent Pterygium

Outcome Measures

Primary Outcomes (1)

• Arrest of progression of the fibrovascular tissue will be measured using slit lamp (width of the lesion in millimeters)

  The width of the lesion will be measured on slit lamp in millimeters

  At 3 month, which is 2 weeks after the last injection

Secondary Outcomes (2)

• Disappearance of redness of the lesion will be assessed using the slit lamp

  At 3 month, which is 2 weeks after the last injection

• Return of conjunctiva to normal thickness will be measured using slit lamp (millimeters)

  At 3 month, which is 2 weeks after the last injection

Study Arms (1)

Avastin and 5 fluorouracil

OTHER

Subconjunctival injection of bevacizumab combined with 5 fluorouracil

Drug: Bevacizumab; Drug: 5 fluorouracil

Interventions

Bevacizumab DRUG

Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium

Also known as: Avastin

Avastin and 5 fluorouracil

5 fluorouracil DRUG

Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium

Also known as: ATC code: L01BC02

Avastin and 5 fluorouracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over the age of 18
• Patients able to give informed consent- Patients with early recurrent pterygium within 6 months of original excision (conjunctival recurrence or recurrence extending just across the limbus).
• Use of effective contraception in females of childbearing age.

You may not qualify if:

• Patients under 18 years of age
• Patients unable or refusing to provide informed consent
• Patients who are needle phobic
• Pregnant women, women aiming for conception and breastfeeding women
• Patients with hypersensitivity to the active substance or to any of the excipients
• Patients with active or suspected ocular or periocular infections.
• Patients with active severe intraocular inflammation.
• Patients with raised intraocular pressure or on glaucoma medication
• Patients with advanced recurrent pterygium that extends between the pupil and limbus at the time of presentation

Sponsors & Collaborators

• University of Nottingham: lead

Related Publications (1)

• Said DG, Faraj LA, Elalfy MS, Yeung A, Miri A, Fares U, Otri AM, Rahman I, Maharajan S, Dua HS. Intra-lesional 5 fluorouracil for the management of recurrent pterygium. Eye (Lond). 2013 Oct;27(10):1123-9. doi: 10.1038/eye.2013.135. Epub 2013 Jun 28.

  PMID: 23807385 BACKGROUND

MeSH Terms

Conditions

Pterygium

Interventions

Bevacizumab; Fluorouracil

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Harminder Dua, Professor

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 21, 2015
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 14, 2017

Record last verified: 2017-11