Download Important Information for Patients (Please read before treatment

Universal House
ERF Way (off Pochin Way)
Middlewich
Cheshire
CW10 0QJ
Tel: 01606 275303
Fax: 01606 835541
Important Information for Patients
(Please read before treatment)
Age-Related Macular Degeneration and treating it
1. What is age-related macular degeneration?
Age-related macular degeneration (AMD) usually occurs in people over 50. It is an
eye condition in which damage to the central part of the retina (the macula) results
in you gradually losing more and more of your central vision. The loss of central
vision makes it difficult for you to see fine detail. You have been referred for an
assessment to see if you have AMD.
2. Treatments for AMD
If you have AMD you may be suitable for treatment with a drug containing antivascular endothelial growth factor (anti-VEGF). This kind of drug slows the
development of new blood vessels and in many cases can stop the disease. Some
patients have even reported improved vision.
Two anti-VEGF drugs are available to ophthalmologists:
bevacizumab (Avastin)
ranibizumab (Lucentis).
3. Using Avastin for treating AMD
A few years ago Avastin gained a license for the treatment of bowel cancer. A
drug gains a license when it is safe, that means it will have side effects but that
these are mild or occur infrequently. A drug will only be considered for a license if
the drug company that makes it asks the licensing agency to do so.
Because of the way Avastin works against cancer some ophthalmologists thought
that it might help in wet AMD and tried it. When the drug company saw that
Avastin did help in wet AMD they decided to produce a new drug, very similar to
Avastin, especially for the treatment of wet AMD. They called this new drug
Lucentis. The drug company asked the licensing agency to consider Lucentis but
not Avastin for a license for treatment of wet AMD. So Lucentis has a license for
wet AMD. Avastin does not have a license for wet AMD as the drug company have
not asked the licensing agency to consider it for one. The National Institute of
Clinical Excellence (NICE) is an agency that looks at whether new drugs work for
the disease they are to be used for, and if the drug does work whether the NHS
can afford to pay for it. NICE can only look at whether drugs work for the disease
they have a license for. So NICE looked at Lucentis for Wet AMD but could not
look at Avastin for wet AMD. NICE said that Lucentis does work for wet AMD and
that the NHS can afford to pay for it.
Data meeting European Union (EU) regulatory standards is not available for the
use of Avastin in wet AMD but is available for use in cancer treatment.
4. Why are we offering you the option of having Avastin if it is not
licensed?
Because:
(a) You will need fewer injections of Avastin. Avastin has a longer life in the eye
when injected compared to Lucentis ( 6 weeks intervals for Avastin and 4
weeks for Lucentis.)
Once a diagnosis of wet AMD is made and the treatment is started, you will
need follow up appointments with your Consultant for at least two years.
The initial treatment is 3 injections (loading dose) of Lucentis or your
consultant will decide how many injections (loading doses) of Avastin are
requied, followed by injections as and when required. This is dependent of the
findings of your OCT scan (Ocular Coherence Tomography).
The studies have shown that with Lucentis you would need 3 or 4 more
injections in one year after the first loading dose of 3 injections, making a tally
of 6 to 7 injections per year or 12 to 14 injections over a two year follow –up
period.
With Avastin, our personal experience and after the results of an audit in
February 2010 which showed that with Avastin there would be fewer injections
over a two year period, as every intravitreal injection is not without
complications, the fewer number of injections means reducing the risk factors.
(b) The BMJ (British Medical Journal which is an international peer reviewed
medical journal) published an article 3 May 2011 about a trail which compared
Avastin and Lucentis. The article stated that “An eagerly awaited trial has
shown that millions of pounds a year could be saved through the use of an
anticancer drug to treat the neovascular or “wet” form of age related macular
degeneration (wet AMD).
The trial showed that bevacizumab (marketed as Avastin) is as effective in
improving sight as ranibizumab (Lucentis), at a fraction of the cost. Although
unlicensed for the condition, bevacizumab is already widely used to treat wet
AMD because its mode of action is similar to that of ranibizumab, earlier trials
have indicated that it works just as well, and using it saves money.
The comparison of age related macular degeneration treatment trials (CATT)
was funded by the US National Institutes of Health to determine whether the
two drugs really are equally good. Its results, reported in the New England
Journal of Medicine (doi: 10.1056/NEJMoa1102673 ), show no difference in
the primary outcome of change in visual acuity.”
(c ) Royal College of Ophthalmologists - Review
The Royal College of Ophthalmologists has today (Wednesday, 14 December
2011) released the conclusions of a working group of leading experts who
reviewed the published scientific literature to assess the efficacy of
ranibizumab (Lucentis) and bevacizumab (Avastin) in the treatment of Age
Related Macular Degeneration (AMD).
The two drugs are anti-VEGF2 agents and the working group concluded that
both are equally effective in the treatment of AMD and have a similar safety
profile.
5. What are the side-effects of Avastin and Lucentis?
Most adverse events are local to the eye and relate to the injection of either drug
into the eye; given that this is an invasive process it is not clear to what extent the
drugs create excess problems above what may be caused just by the injection.
Most complications are minor and resolve within a few days and consist of
symptoms such as itching, dryness, watering and inflammation and could be due
to localised swelling of conjunciva (thin superficial layer covering the sclera, which
is the white of the eye) or localised haemorrhage (bleed) under the conjunctiva
which resolves itself gradually over a period of 7 to 10 days.
Sometimes patients may experience discomfort, pain or sensitivity to light due to
minor abrasions (scratches) over the cornea (Which acts as a window to the eye).
If the symptoms are of that of pain, please contact your treatment centre as
follows:
Leighton Hospital switchboard - Tel: 01270 255141 – ask to speak to the Triage
Nurse or an On-Call Doctor
Eyecare Medical Ltd – Tel: 07804965332 – ask to speak to the Practice
Ophthalmic Nurse
A very small percentage develop more serious complications such as detachment
of the retina or vitreous, bleeding inside the eye, raised pressure in the eye and
infections of the eye. Some of these complications will usually resolve with prompt
treatment but it depends on the severity especially with complications like infection
and retinal detachment.
If the symptoms are of that of pain, blurred vision with or without a red eye please
contact your treatment centre:
Leighton Hospital Switchboard - Tel: 01270 255141 – and ask to speak to the
Triage Nurse or an on-call doctor
Eyecare Medical Ltd - Tel: 0776 9966259
More rarely serious complications develop including cataract and blindness.
Injections may be associated with systemic illness including cough, nausea,
headaches, allergy, joint pain, nasopharyngitis, anxiety, high blood pressure and
stroke. It Is not clear to what extent these diseases are coincidental or causative
given the average age of people who have the injections.
The benefits and risks of using Avastin and Lucentis for wet AMD are not yet fully
known. Also Avastin and Lucentis does not work for everyone with wet AMD so
your eye disease may not get better or may even get worse.
6. Switching from One Anti-VEGF to another Anti-VEGF :
In rare instances if for some reason if the opted Anti-VEGF does not work (due to
polymorphism in complement factor H gene) we can switch from one to the other.
7. Where will treatment take place?
Central and Eastern Cheshire PCT (NHS) will pay for treatment, but it will be
expected to take place at either:
Mid Cheshire Hospitals Foundation Trust, (Leighton Hospital)
Middlewich Road,
Crewe,
CW1 4QJ
OR
Eyecare Medical Limited,
Vision House,
Gunco Lane,
Macclesfield,
SK11 7JW
The doctors giving the treatment are accredited consultant ophthalmologists. The
treatment will be to NHS standards and will be exactly the same as you would get
in the NHS, including access to NHS complaints procedures.
8. Choosing whether to have Avastin or Lucentis
If your consultant decides that you are suitable for treatment, they will give you a
choice after:
(a) Explaining the advantages and disadvantages of Lucentis and Avastin
(b) For clinical reasons, which drug will be more effective to treat you either using
Lucentis, or Avastin
(c) If you specifically want to be treated with one particular drug the consultant will
explain to you about the flexibility of changing from one over to the other if the
response after the loading dose of one particular dose is not good or if you
happen to develop side effects to one particular drug.
Central and Eastern Cheshire Primary Care Trust and the doctors treating you
believe that Avastin is safe and effective and more than 70% of Central and
Eastern Cheshire patients are treated with Avastin for wet AMD.
If you have questions, please ask your Optometrist or GP. You can also ask your
consultant questions when you see him or her in the clinic.