Download `wet` age-related macular degeneration pre NICE inclusion criteria

Consent Information for Avastin (Bevacizumab) Intravitreal
Injection for ‘wet’ age-related macular degeneration (AMD)
for patients whose vision is too good/outside NICE criteria
for treatment with Lucentis (Ranibizumab) or Eylea
(Aflibercept).
Background
Wet age-related macular degeneration is the commonest cause of blindness in the
UK.
Treatment for wet AMD involves the use of eye injections of “anti-VEGF” medications
(active against Vascular Endothelial Growth Factor), including Lucentis, Eylea and
Avastin.
These drugs mostly stabilise vision hence it is important to start treatment as early as
possible, preferably before the vision has deteriorated.
The National Institute of Health and Care Excellence (NICE) recommends the use of
the expensive licensed drugs Lucentis (ranibizumab) or Eylea (aflibercept) for patients
whose visual acuity is between 6/12 and 6/96.
An increasing number of patients are seen in the eye clinic with wet AMD but with
vision better than 6/12 and at present the licensed treatments are not funded by the
NHS in England for this group of patients. The commissioners of South Devon will
however fund a cheaper similar drug, Avastin, which has been shown to be no less
effective and have no additional side effect compared with Lucentis in several large
multicentre trials. Avastin is not licensed for injection into the eye, but is commonly
used ‘off label’ to treat wet AMD privately in the UK and has been widely used in other
countries, including the USA, for several years.
The choice is therefore waiting for your vision to deteriorate to a level that it will be
eligible for funding with licensed treatments or having treatment now with an
unlicensed drug Avastin to try and prevent further loss of vision.
This document explains the risks and benefits of this treatment.
What is Avastin? How good is it?
Avastin is an “anti-VEGF” drug that is used to block the action of a chemical called
vascular endothelial growth factor (VEGF). This chemical is produced in excess in
some diseases relating to the blood vessels and circulation of the eye, including “wet
age-related macular degeneration”.
Avastin is similar in its action to Lucentis and Eylea with major trials in the USA and
UK proving it has comparable benefits in wet age-related macular degeneration.
The goal of the treatment is to prevent further loss of vision, although some patients
do regain some vision. Avastin, like Lucentis and Eylea, may not restore vision that
has already been lost and may not prevent further loss of vision caused by the
disease in all patients.
Is Avastin a licensed treatment?
Avastin is a licensed drug but it is not licensed for the treatment of eye disease or
injection into the eye. It was approved for the treatment of certain forms of bowel
cancer. However, doctors may use medications ‘off-label’ to treat other conditions if
there is medical evidence to suggest its use may offer benefits especially when
licensed treatments are not available (as is currently the case for patients whose
vision is better than 6/12 with wet age-related macular degeneration).
‘Off-label’ Avastin is widely used by ophthalmologists throughout the world and the
available information suggests positive benefits for a number of eye diseases,
including wet age-related macular degeneration.
What other treatment options are available?
At present the choice is having Avastin now or waiting until your vision deteriorates to
6/12 or worse before being eligible to start treatment with Lucentis or Eylea, according
to NICE criteria.
The disadvantage of waiting is that the vision can sometimes deteriorate rapidly and
does not always recover the lost vision when the licensed treatments are started.
These options will be explained to you by your eye doctor or nurse.
You do not have to receive treatment for your condition. However, without treatment
your vision is very likely to get worse and may progress to a point where treatment will
no longer help.
When receiving Avastin treatment you will be offered the option of switching to
Lucentis or Eylea if your vision falls to a level where these drugs are funded.
How is Avastin given?
Your pupil (black part of your eye) will be dilated and anaesthetic drops will be put in
to numb the surface of your eye. The skin around the eye and the surface of your eye
is washed with an antibacterial solution to reduce the risk of infection. The drug
(Avastin) is injected into the vitreous humour (the jelly like substance inside the back
of your eye). This is the same method of administration as is used for Lucentis or
Eylea.
You are likely to need a number of injections over a course months or years. This will
depend on your eye condition and how it responds to treatment.
It is usually necessary to attend for eye examinations and/or injections on a frequent
basis (sometimes monthly) for several years.
What are the risks of treatment?
The potential risks are outlined below and will be discussed with you by your eye
doctor. As with any medicine side effects are possible with Avastin. However, not
everyone who takes the drug will experience side effects and overall the risks from
treatment are very low.
Complications of Avastin in other body parts
There may be a slight increased risk of experiencing blood clots (which may cause
heart attack or stroke) after intravitreal injection of medicines such as Avastin. Other
possible side effects include high blood pressure and bleeding from parts of the bowel.
Although these side effects have been reported in patients receiving Avastin in large
doses through the vein when used to treat cancer there is currently no conclusive
evidence of an increased risk from using tiny doses in the eye.
Risks of intravitreal eye injections
Serious complications of the intravitreal injection procedures include bleeding,
infection (endophthalmitis), cataract formation and retinal detachment. These risks
related to the injection procedure and are not specific to Avastin and also exist for
injection with Lucentis or Eylea. Any of these serious complications may lead to
severe, permanent loss of vision. The overall risk of sight threatening complications
over a long term course of treatment is estimated at about 1% (1 in 100) or less. The
risks will be explained and discussed with you before you agree to treatment. Without
treatment wet age-related macular degeneration usually causes severe permanent
loss of vision in the vast majority of cases.
More common side effects may include:
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Temporary eye pain often relieved by pain killers
Conjunctival haemorrhage (bloodshot eye)
Vitreous floaters
Irregularity or swelling of the cornea
Inflammation of the eye
Visual disturbances such as small specks in the vision.
Coincidental risks
Whenever a medication is used in a large number of patients coincidental problems
may occur that have no relationship to the treatment, particularly in an elderly
population. For example, patients with high blood pressure or smokers are already at
increased risk for heart attacks and strokes. If one of these patients being treated with
Avastin suffers a heart attack or stroke, it is probably caused by the high blood
pressure and or smoking and not the Avastin treatment.
The treatment might not be effective for you
Your condition may not get better or may become worse despite these
injections. Any or all of the complications described above may cause decreased
vision and/or have a possibility of causing blindness. Additional procedures may be
needed to treat these complications.
During follow up visits you will be checked for possible side effects and the results will
be discussed with you.
Patient responsibilities
You must immediately contact the hospital on the numbers given if any of the following
signs of infection or complications develop:
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Severe pain
Blurred or reduced vision
Sensitivity to light
Redness of your eye (increasing compared to immediately after your injection)
Sticky discharge from your eye
You should avoid rubbing your eyes or swimming for three days following each
injection to reduce the risk of infection.
Please keep all post injection appointments so that potential complications can be
checked for.
Although the likelihood of serious complications affecting other organs of your body is
low, you should immediately contact your GP or attend your local Accident and
Emergency Department if you experience:
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Abdominal pain
Abnormal bleeding
Chest pain
Severe headache
Slurred speech
Sudden limb numbness or weakness
What if I change my mind?
If you have any concerns, please discuss these with the doctor. You can change your
mind about your treatment at any time.
If you require further advice or do not understand anything contained in this leaflet
please ask your ophthalmologist or you can contact our Macula Coordinator at Torbay
Hospital on 01803 655179.
If you experience any problems related to your eye injections, there is an on-call
ophthalmologist available 24/7 who can be contacted by your GP, optician or via a
visit to A&E (for emergencies only). We do not operate a walk-in eye casualty.
Further information
Royal National Institute of Blind People. (RNIB)
Find out more at www.rnib.org.uk or phone the RNIB Helpline on
0303 123 9999 available Monday – Friday 8.45 am – 5.30 pm.
The Macular Society.
Find out more at www.macularsociety.org or contact the Macular Society. For
General enquiries telephone 01624350551or e-mail [email protected] or for
the helpline 0300 3030 111 or e-mail [email protected]
25357 V1/Ophthalmology/TSDFT/02.17/Review Date 02.19