Strategies for management of recurrence of fibrous tissue and blood vessels on the surface of the eye

Phase 1

• Conditions: RECURRENT PTERYGIUM; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2015-003217-20-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-03
• Study Completion: 2018-04-11
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

-Patients over the age of 18
-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). Recurrence will be defined as follows:
1.Increased vascularity of the conjunctiva at the site of original excision and autologous conjunctival grafting, showing tortuous and dilated vessels associated with thickening/oedema of the conjunctiva appearing after the initial redness and swelling related to surgery had settled.
2.Clinically documented progression of fibrovascular tissue over two or more follow-up visits with or without frank encroachment on to the cornea, which did not settle with increased doses of topical steroids

-Use of effective contraception in females of childbearing age

There is no evidence in the literature that it affects spermatogenesis in men who are aiming to father a child therefore should not need to be excluded from the study. Therefore we will not exclude them from the study but we will inform them clearly that there is no evidence in literature regarding whether Avastin® can affect sperm.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the efficacy of combined 5FU and Avastin injections in the treatment of recurrent pterygium.;<br> Secondary Objective: The secondary outcome will be disappearance of redness, return to normal thickness after the injections are stopped.<br> ;Primary end point(s): Arrest of progression of the fibrovascular tissue ;Timepoint(s) of evaluation of this end point: At 3 month, which is 2 weeks after the last injection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary outcome will be disappearance of redness, return to normal thickness after the injections are stopped.;Timepoint(s) of evaluation of this end point: At 3 month, which is 2 weeks after the last injection