Condition category
Eye Diseases
Date applied
06/09/2010
Date assigned
25/10/2010
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.moorfields.nhs.uk/Home

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23087419

Publication citations

  1. 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.

Additional files

Editorial Notes