Pilot randomised placebo-controlled double-masked clinical trial of subconjunctival Bevacizumab on eyes with recent onset of corneal neovascularisatio

• Conditions: Corneal neovascularisation; MedDRA version: 9.1Level: LLTClassification code 10055665Term: Corneal neovascularisation

• Registration Number: EUCTR2008-007984-17-GB
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-24
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

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

Inclusion Criteria

Patients with clinical features of corneal neovascularization of recent onset. Both superficial and deep neovascularization will be recruited with no attempt to stratify these patients. The conditions that will be recruited for enrolment will include:

1.Infective corneal diseases
a.Post bacterial/fungal/amoebic keratitis
b.Herpetic keratitis
2.Corneal lnflammatory conditions
a.Corneal graft rejection
b.Corneal suture/ post surgical vascularisation
c.Ocular rosacea
d.Contact lens associated vascularisation
e.Peripheral corneal ulceration and melting disorders
f.Chemical injury
3.Systemic inflammatory conditions
a.Stevens-Johnson syndrome
b.Mucus membrane pemphigoid
c.Atopic keratoconjunctivitis

Will include the following:
•Male or female over 18 years of age
•Presence of blood vessels extending 2 mm form the limbus onto the cornea
•Co-existent condition from list above causing neovascularisation that is
present for no more than 6 months
•Ability to understand and provide consent to participate in the study and
willingness to follow study instructions and likely to complete all required
visits

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Patients with corneal neovascularization of greater than 6 months duration
•Presence of corneal conditions that may be worsened with bevacizumab
including active corneal melting, persistent epithelial defects, active
infective keratitis
•a history of cardiovascular or cerebro-vascular event in the previous 6
months
•Uncontrolled hypertension defined as systolic blood pressure >160 mmHg
or diastolic blood pressure >90mmHg
•Pregnancy or breastfeeding.
•Current or recent (<3 months) use of bevacizumab into the study eye
•Patient with history of steroid responsiveness or uncontrolled intraocular
pressure

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Safety and efficacy of Avastin in corneal neovascularisation;Secondary Objective: 1. Change in visual acuity<br>2. Change in corneal signs<br>3. Change in normal conjunctival blood vessels<br>4. Adverse events<br>5. Accuracy of physician assessments<br>6. Patient evaluation of intervention;Primary end point(s): Change in area of corneal neovascularisation, on digital photography, from baseline to 3 months