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Strategies for Management of Recurrent Pterygium (REPEAT)

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ClinicalTrials.gov Identifier: NCT02530801
Recruitment Status : Active, not recruiting
First Posted : August 21, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

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.


Condition or disease Intervention/treatment Phase
Recurrent Pterygium Drug: Bevacizumab Drug: 5 fluorouracil Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Recurrent Pterygium to Prevent Visual Impairment
Actual Study Start Date : January 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Avastin and 5 fluorouracil
Subconjunctival injection of bevacizumab combined with 5 fluorouracil
Drug: Bevacizumab
Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium
Other Name: Avastin
Drug: 5 fluorouracil
Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium
Other Name: ATC code: L01BC02



Primary Outcome Measures :
  1. Arrest of progression of the fibrovascular tissue will be measured using slit lamp (width of the lesion in millimeters) [ Time Frame: At 3 month, which is 2 weeks after the last injection ]
    The width of the lesion will be measured on slit lamp in millimeters


Secondary Outcome Measures :
  1. Disappearance of redness of the lesion will be assessed using the slit lamp [ Time Frame: At 3 month, which is 2 weeks after the last injection ]
    Images will be taken using anterior segment slit lamp camera and will be compared for redness by 2 different observers

  2. Return of conjunctiva to normal thickness will be measured using slit lamp (millimeters) [ Time Frame: At 3 month, which is 2 weeks after the last injection ]
    The thicknessof the lesion will be measured on slit lamp in millimeters



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530801


Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Harminder Dua, Professor University of Nottingham

Publications:
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT02530801     History of Changes
Other Study ID Numbers: 15073
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Bevacizumab
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors