Strategies for Management of Corneal Neovascularisation
Management of Active and Established Corneal Neovascularisation to Prevent Visual Impairment
2 other identifiers
interventional
40
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2015
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedStudy Start
First participant enrolled
December 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedDecember 2, 2015
December 1, 2015
1.7 years
October 27, 2015
December 1, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Improved/maintained Snellen's visual acuity
10 months
Decreased corneal opacity related to lipid deposition
10 months
Reduced episodes of graft rejection(in corneal graft patients)
10 months
Study Arms (2)
Fine needle Diathermy
ACTIVE COMPARATORFine needle Diathermy(FND) will be applied under topical anaesthesia under an operating microscope. This involves the insertion of a fine corneal suture needle in the vicinity of the vessels and using this as an extension of the probe of a monopolar cautery to deliver the energy in the corneal tissue at the site at which it is required to occlude the vessels.
Fine Needle Diathermy and Bevacizumab
ACTIVE COMPARATORFine needle Diathermy(FND) will be applied under topical anaesthesia under an operating microscope. This involves the insertion of a fine corneal suture needle in the vicinity of the vessels and using this as an extension of the probe of a monopolar cautery to deliver the energy in the corneal tissue at the site at which it is required to occlude the vessels. Patients will receive subconjunctival injections of bevacizumab in the conjunctiva near the limbus in the quadrant(s) affected (total volume of between 0.2 ml-0.3 ml of the 2.5 mg/0.1 ml solution). The subconjunctival injections will be administered after FND in the same treated quadrants.
Interventions
Fine needle diathermy is a surgical procedure that is used in the treatment of corneal NV. It is a safe and effective method for corneal vessels occlusion.
Bevacizumab is a humanized monoclonal antibody that binds to isoforms of VEGF-A .
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harminder S Dua, Professor
University of Nottingham
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2015
First Posted
November 3, 2015
Study Start
December 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2018
Last Updated
December 2, 2015
Record last verified: 2015-12