Subconjunctival bevacizumab on eyes with recent onset of cornea neovascularisation

ISRCTN	ISRCTN35052615
DOI	https://doi.org/10.1186/ISRCTN35052615
Protocol serial number	PETC1002
Sponsor	Moorfields Eye Hospital NHS Foundation Trust (UK)
Funder	Special Trustees of Moorfields Eye Hospital (UK) (awarded 05/01/2009; ref: PETC1002)

Submission date: 06/09/2010
Registration date: 25/10/2010
Last edited: 01/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Stephen Tuft
Scientific

162 City Road
London
EC1V 2PD
United Kingdom

Email	s.tuft@ucl.ac.uk

Study information

Primary study design	Interventional
Study design	Prospective placebo-controlled double-masked randomised clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Pilot randomised placebo-controlled double-masked clinical trial of subconjunctival bevacizumab on eyes with recent onset of cornea neovascularisation
Study objectives	Subconjunctival bevacizumab is additionally effective to topical preservative free dexamethasone 0.1% in the treatment of recent onset corneal neovascularisation.
Ethics approval(s)	National Research Ethics Service East London and the City Ethics Committee 1 approved on the 02/03/2009 (ref: 09/H0703/2)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Bevacizumab, dexamethasone
Primary outcome measure(s)	Change in area of corneal neovascularisation at 3 months compared to baseline by image analysis of digital slit lamp photos
Key secondary outcome measure(s)	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
Completion date	16/08/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	30
Key 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
Key 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
Date of first enrolment	27/04/2009
Date of final enrolment	16/08/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

162 City Road

London
EC1V 2PD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2013		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes