Corneal Neovascularisation Clinical Trial
Official title:
Management of Active and Established Corneal Neovascularisation to Prevent Visual Impairment
The cornea is the transparent window of the eye, which allows light to enter into the eye
and also contributes to the focusing of the light rays. One of the major factors responsible
for its transparency is the lack of blood vessels. However, following inflammation new blood
vessels (corneal vascularisation [CVas]) grow into the cornea affecting its transparency and
impairing vision. CVas leads to further damage in the form of scarring,oedema,fat deposition
and is a major cause of corneal graft rejection.
In 2000 with ethical approval (OY129801) the investigators developed and published a
clinical technique called Fine Needle Diathermy occlusion of corneal vessels (FND). This has
proven very successful for occluding established vessels and is practiced in many centers
across the world. Recently it has been demonstrated that by inhibiting a chemical stimulant
of vessel formation called vascular endothelial growth factor(VEGF) active new vessel growth
in the retina can be suppressed. The approach is also being used for corneal new vessels.
Bevacizumab (Avastin) is a chemical inhibitor of VEGF and is used extensively to treat
retinal new vessels in macular degeneration. Avastin has been shown to be effective and safe
in treating corneal new vessels. The investigators propose to evaluate the efficacy and
safety of FND alone and FND combined with Avastin in treatment of CVas.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | August 2018 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients over the age of 18 - Able to give informed consent - With corneal neovascularisation non responsive or not suitable for conventional steroid therapy - Use of effective contraception in females of childbearing age Exclusion Criteria: - Patients under 18 years of age - Patients unable or refusing to provide informed consent - Patients who are needle phobic - Pregnant women, women aiming for conception and breastfeeding women - Patients with hypersensitivity to the active substance or to any of the excipients - Patients with active or suspected ocular or periocular infections. - Patients with active severe intraocular inflammation. - Patients with raised intraocular pressure or on glaucoma medication |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Nottingham |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decreased corneal neovascularisation | A comparison of total vascularisation of the corneal area as measured by our grading system (Faraj LA et al, 2015) before and after treatment. | 6 months | No |
Secondary | Improved/maintained Snellen's visual acuity | Visual acuity is assessed using Snellen chart and vision is expressed in LOGMAR units | 10 months | No |
Secondary | Decreased corneal opacity related to lipid deposition | The response to treatment will be judged clinically by biomicroscopy examination and quantitatively by comparison with pre-treatment slit lamp photographs. The comparison of the pre and post treatment slit lamp images will be done by two independent blind reviewers. | 10 months | No |
Secondary | Reduced episodes of graft rejection(in corneal graft patients) | Number of rejection episodes will be recorded | 10 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01843101 -
Investigation of Different Scanning Protocols for 3 Dimensional High-resolution Imaging of the Human Cornea With Optical Coherence Tomography (OCT) - A Pilot Study
|
Phase 2 |