Strategies for Management of Corneal Neovascularisation

Sponsor
University of Nottingham
Study ID
NCT02594423
Phase
PHASE4
Status
Unknown

Conditions

  • Corneal Neovascularisation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fine Needle Diathermy — DEVICE
    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 — DRUG
    Bevacizumab is a humanized monoclonal antibody that binds to isoforms of VEGF-A .

Study Details

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.

Key Dates

First listed
Nov 3, 2015
Start date
Dec 31, 2015
Status verified
Dec 2015
Primary completion
Aug 31, 2017
Completion
Aug 31, 2018

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fine needle Diathermy
    Fine 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.
  • Active Comparator: Fine Needle Diathermy and Bevacizumab
    Fine 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.

Primary Outcome Measure

Decreased corneal neovascularisation [ Time Frame: 6 months ]

Central Contacts