Subconjunctival bevacizumab on eyes with recent onset of cornea neovascularisation
| ISRCTN | ISRCTN35052615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35052615 |
| Secondary identifying numbers | 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
Scientific
162 City Road
London
EC1V 2PD
United Kingdom
| s.tuft@ucl.ac.uk |
Study information
| Study design | Prospective placebo-controlled double-masked randomised clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 27/04/2009 |
| Completion date | 16/08/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
162 City Road
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
Sponsor information
Moorfields Eye Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
162 City Road
London
EC1V 2PD
England
United Kingdom
| Isabel.Moldon@moorfields.nhs.uk | |
| Website | http://www.moorfields.nhs.uk/Home |
"ROR" |
https://ror.org/03zaddr67 |
Funders
Funder type
Hospital/treatment centre
Special Trustees of Moorfields Eye Hospital (UK) (awarded 05/01/2009; ref: PETC1002)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
