Contact information
Type
Scientific
Primary contact
Mr Stephen Tuft
ORCID ID
Contact details
162 City Road
London
EC1V 2PD
United Kingdom
s.tuft@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PETC1002
Study information
Scientific title
Pilot randomised placebo-controlled double-masked clinical trial of subconjunctival bevacizumab on eyes with recent onset of cornea neovascularisation
Acronym
Study hypothesis
Subconjunctival bevacizumab is additionally effective to topical preservative free dexamethasone 0.1% in the treatment of recent onset corneal neovascularisation.
Ethics approval
National Research Ethics Service East London and the City Ethics Committee 1 approved on the 02/03/2009 (ref: 09/H0703/2)
Study design
Prospective placebo-controlled double-masked randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Corneal neovascularisation
Intervention
The intervention is subconjunctival bevacizumab or placebo by subconjunctival injection. The treatment protocol for each intervention will be:
1. Subconjunctival bevacizumab (active arm): a volume of 0.1 ml of 25 mg/ml bevacizumab will be injected into the subconjunctival space 2 mm from the limbus at the area of most active neovascularisation. Injections will be repeated at week 4 and 8 unless prevented by any adverse event.
2. Subconjunctival saline (placebo arm): a syringe exactly the same in appearance to the above bevacizumab treatment will be prepared by Pharmacy but containing only 0.1 ml of normal saline solution. This will be injected by the same investigator, blinded to the contents of the syringe.
Conventional treatment:
Standard therapy be given to all patients and is will involve defined as dexamethsone 0.1% preservative free solution to be instilled at 4 times per day for the first month and then increasing or decreasing according to neovascularisation response.
Intervention type
Drug
Phase
Phase II/III
Drug names
Bevacizumab, dexamethasone
Primary outcome measure
Change in area of corneal neovascularisation at 3 months compared to baseline by image analysis of digital slit lamp photos
Secondary outcome measures
Measured from baseline to 3 months:
1. Change in visual acuity
2. Change in corneal signs including:
2.1. Presence of and size of epithelial defects
2.2. Signs of corneal melting or thinning using pentacam
2.3. Lipid keratopathy
2.4. Central endothelial cell counts using specular microscopy
2.5. Changes in lumen diameter of main vessels
2.6. Indirect assessments of vessel permeability change in area of lipid keratopathy, corneal clarity by pentacam imaging
3. Change in normal conjuncitval blood vessels. Systematic digital photos of 4 quadrants of each patients conjunctiva will also be taken and compared after 3 months of treatment. The aim is to see whether bevacizumab may have an effect in reducing normal blood vessels during the treatment period compared to the control group.
4. The proportion of adverse events in each arm
5. Physician assessment of improvement compared with digital assessment
Overall trial start date
27/04/2009
Overall trial end date
16/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female over 18 years of age
2. Presence of blood vessels extending 2 mm form the limbus onto the cornea
3. Co-existent corneal condition causing neovascularisation that is present for no more than 6 months
4. Ability to understand and provide consent to participate in the study and willingness to follow study instructions and likely to complete all required visits
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Patients with corneal neovascularisation of greater than 6 months duration
2. Presence of corneal conditions that may be worsened with bevacizumab including active corneal melting, persistent epithelial defects, active infective keratitis
3. A history of cardiovascular or cerebro-vascular event in the previous 6 months
4. Uncontrolled hypertension defined as systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 90mmHg
5. Pregnancy or breastfeeding
6. Current or recent (less than 3 months) use of bevacizumab into the study eye
7. Patient with history of steroid responsiveness or uncontrolled intraocular pressure
8. Subject hypersensitive to bevacizumab
Recruitment start date
27/04/2009
Recruitment end date
16/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
162 City Road
London
EC1V 2PD
United Kingdom
Sponsor information
Organisation
Moorfields Eye Hospital NHS Foundation Trust (UK)
Sponsor details
162 City Road
London
EC1V 2PD
United Kingdom
Isabel.Moldon@moorfields.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Special Trustees of Moorfields Eye Hospital (UK) (awarded 05/01/2009; ref: PETC1002)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23087419
Publication citations
-
Results
Petsoglou C, Balaggan KS, Dart JK, Bunce C, Xing W, Ali RR, Tuft SJ, Subconjunctival bevacizumab induces regression of corneal neovascularisation: a pilot randomised placebo-controlled double-masked trial., Br J Ophthalmol, 2013, 97, 1, 28-32, doi: 10.1136/bjophthalmol-2012-302137.