• Reference Number: HEY-918/2023
• Departments: Ophthalmology Department
• Last Updated: 31 May 2023

Introduction

This leaflet has been produced to give you general information.  Most of your questions should have been answered by this leaflet.  It is not intended to replace the discussion between you and the healthcare team, but may act as a starting point for discussion.  If after reading it you have any concerns or require further explanation, please discuss this with a member of the healthcare team.

What is Age-related Macular Degeneration?

Age-related Macular Degeneration (AMD) is a condition affecting the central part of the retina (the nerve layer at the back of the eye) called the ‘Macula’. The retina is a thin layer of nerve cells similar to the film in a camera and in order to function it needs to remain as a thin crisp layer.

There are two forms of AMD – ‘dry’ and ‘wet’. Dry AMD is a gradual deterioration of the macula as the retinal cells die off and are not renewed. There is currently no treatment for dry AMD. In wet AMD, abnormal blood vessels grow into the macula. These leak fluid and may bleed into the retinal nerve layer so that it becomes water-logged and unable to function. Patients often notice this fluid when their vision becomes distorted and straight lines are seen as wavy.

Wet AMD can develop very suddenly. It can now be treated if caught quickly. If left untreated the blood and leakage will permanently damage the retinal nerve cells and eventually produce scarring which is currently irreversible. In this advanced disease the patient would have no detailed central vision but would keep their field of vision and so still be able to catch sight of objects “out of the corner of their eye”.

What treatments are available for Wet AMD?

Wet AMD can be treated if caught early. At present the most effective treatment is in the form of injections of anti-VEGF agents into the eye.

Anti-VEGF injections: Lucentis (Ranibizumab), Eylea (Aflibercept), Beovu (Brolucizumab) and Vabysmo (Faricimab).  These drugs block the action of a molecule, Vascular Endothelial Growth Factor (VEGF), in the eye which makes blood vessels leaky and so cause waterlogging of the macula. Lucentis and Eylea are licensed for use in wet AMD and have been extensively studied in research clinic trials. There is no evidence that one drug produces better vision than the other. The effect of these injection treatments is temporary so they must be given repeatedly potentially for several years. Patients receive 4 injections, 1 injection every month, as an automatic loading course. Patients will have an eye scan and vision test every visit and this information is used to decide the spacing between further injections after the loading dose. These injections are given over a prolonged period depending on how well the eye responds.

Biosimilar Ranibizumab, which is a similar copy of the original Ranibizumab, manufactured by different pharmaceutical companies is also available for use. This is shown to have the same safety and effectiveness as original Ranibizumab but less expensive.

Vabysmo is a new anti-VEGF drug, recently licensed for use in wet AMD. Apart from blocking the VEGF molecule, it also blocks another molecule called Angiopoietin-2. Current evidence suggests that Vabysmo may last for longer than the other anti-VEGF drugs, potentially reducing the required number of injections over a period of time.

Monitoring

Some patients with Wet AMD have a particular pattern of blood vessels growing beneath the retina, which may remain stable without treatment. In this case it is advisable to wait before commencing injection treatment for a short period of monitoring to confirm if the disease is progressing or not. This approach is because of the small risk to vision with the treatment.

In patients with excellent vision and early Wet AMD the risks of treatment may also outweigh the benefits. Current NHS (NICE) guidance is that patients with very good vision should be monitored initially and only treated if the vision starts to deteriorate in view of the small risk involved with the treatment.

Are there any treatment benefits for patients with very poor vision due to Wet AMD?

Unfortunately, there is no research evidence that injection treatment will work once vision drops in the eye below a certain level. On the standard eye

chart this level equals the ability to read the top letter at 3 metres. At this stage the disease has advanced too far because scar tissue has irreversibly damaged the retina. To proceed with treatment in this situation would be to put the eye at a risk of total loss of vision for no benefit. Such patients will in all probability remain stable; this disease will never reduce peripheral vision and so there is no risk that the eye will deteriorate to complete blindness.

There are other practical measures which can help each individual to make the best use of their remaining vision should the disease progress to this stage. The Low Vision Clinic within the Eye clinic at Hull Royal Infirmary is able to assess each patient individually and recommend the most useful visual aids.

Other treatments for Wet AMD

Avastin (Bevacizumab) is an anti VEGF agent and has been shown to have effects similar to Lucentis and Eylea but is not licensed for use in the eye and hence it is not used in this hospital to treat Wet AMD.

Photodynamic therapy (PDT) was the standard treatment for Wet AMD before anti VEGF injections became available. Patients receive an infusion of dye into the vein, which is light-activated by a cold laser; this is repeated every 3 months until the blood vessels stop leaking.

Only certain types (patterns) of blood vessels growing beneath the retina will respond to PDT. This means that only on average 1 patient in every 4 with Wet AMD would be eligible for treatment. As with injection treatment, there is also a small risk that PDT could make the vision worse and patients with advanced disease do not benefit.

The chances of a good result with PDT are lower than with anti VEGF injections. In particular only 5% of patients treated with PDT have a big increase in vision compared to 30-40% treated with injections. Hence anti VEGF injections have become the standard treatment for all forms of Wet AMD.

Will the treatment help?

Anti VEGF injection treatment has the following potential benefits:

• 90-95% chance of avoiding severe loss of central vision in the eye treated. 
• 70% chance of keeping the vision as it was when treatment began OR of a small improvement in vision.
• 30-40% chance of a big improvement in vision i.e. of regaining a large amount of the vision that has been lost.

Are there any complications and risks with injection treatment?

Like all medicines, anti-VEGF treatment can cause side effects, although not everybody gets them. The side effects are either from the medicine itself or from the injection procedure.  Most of the side-effects involve the eye alone.

Common side-effects include discomfort during and after injection, bruising of the white of the eye, an increase in the eye pressure and moving black dots in your vision.

Less common side-effects include inflammation in the eye, bleeding, infection, retinal tear, detached retina and cataract.

Regardless of the drug is used, each injection procedure carries a small risk (1:1000) of serious complication including infection inside the eyeball (endophthalmitis) which can potentially result in total loss of vision if not treated promptly (see Information for Patients Under-Going Intravitreal Injections leaflet).

All of these side-effects may occur with each of the available medicines. Inflammation and an immune response (“immunogenicity”) appears to be more common with brolucizumab (Beovu) than with the other medicines. Around 1:100 patients treated with brolucizumab (Beovu) will experience permanent loss of vision due to inflammation over the course of treatment.

There are no proven risks to your general health with this course of injections.

None of the injection treatments have been tested on pregnant women and therefore should be used with caution in women of child bearing age.

For some patients the risks of treatment will outweigh the benefits and for others the eye may be too badly affected to make treatment worthwhile.

How do I come prepared for injection treatment?

Please read the Injection information leaflet.  Share the information it contains with your partner and family (if you wish) so that they can be of help and support.  There may be information they need to know, especially if they are taking care of you following this examination.

Please eat and drink as usual on the day of the treatment. Please bring your usual diabetic medications with you, especially insulin, if the timing of your visit coincides with your usual medication times. It would be sensible to bring a snack in case of any delays, although this is unlikely to happen.

Please do not drive to your appointment as you will be having dilating drops in your eye/s under-going treatment and should not drive for up to 6 hours afterwards as your vision will be blurred.

The treatments are all done as day case/out-patient procedures and you will not be staying in hospital overnight.

What will happen?

When you attend for an injection appointment please report to the Main reception Desk in the Eye Hospital. You will be directed to the correct waiting area in the Eye clinic.

A nurse will check your details with you and you will have dilating drops in the eye/s to be treated. You will also have a vision test and an eye scan.

The injection would be performed in a clean room in the eye clinic. The eye will be numbed with local anaesthetic drops before the injection procedure. The injection is performed with you reclining on a couch, the eyelids are cleaned and cleaning solution is used in the eye and a clear sheet placed over the eyes/forehead. The injection is given from the side so that you will not be able to see the procedure, although you may be aware of pressure on or around the eye.

You will be able to go home the same day.

What happens afterwards?

Immediately after the injection, your eye may feel slightly sore/ watery and may be blood shot but this is normal and these symptoms will soon wear off. Your vision will be blurred until the effect of the dilating drops have worn off.

You will be given instructions about what to do if you think there is a more serious problem with your eye after the injection. You will also be given emergency contact telephone numbers before you leave the department. You will also be advised about your follow up visit.

It is important to contact the Eye Clinic urgently if you experience any of the following symptoms:

• A sudden decrease or change in your vision, including a sudden increase in the number of small floaters or flashing lights in your vision
• Pain, increased discomfort or redness of your eye
• Increased sensitivity to light

Should you require further advice on the issues contained in this leaflet, please do not hesitate to contact the Ophthalmology Department (01482) 608788 or 604346

General Advice and Consent

Most of your questions should have been answered by this leaflet, but remember that this is only a starting point for discussion with the healthcare team.

Consent to treatment

Before any doctor, nurse or therapist examines or treats you, they must seek your consent or permission. In order to make a decision, you need to have information from health professionals about the treatment or investigation which is being offered to you. You should always ask them more questions if you do not understand or if you want more information.

The information you receive should be about your condition, the alternatives available to you, and whether it carries risks as well as the benefits. What is important is that your consent is genuine or valid. That means:

• you must be able to give your consent
• you must be given enough information to enable you to make a decision
• you must be acting under your own free will and not under the strong influence of another person

Information about you

We collect and use your information to provide you with care and treatment. As part of your care, information about you will be shared between members of a healthcare team, some of whom you may not meet. Your information may also be used to help train staff, to check the quality of our care, to manage and plan the health service, and to help with research. Wherever possible we use anonymous data.

We may pass on relevant information to other health organisations that provide you with care. All information is treated as strictly confidential and is not given to anyone who does not need it. If you have any concerns please ask your doctor, or the person caring for you.

Under the General Data Protection Regulation and the Data Protection Act 2018 we are responsible for maintaining the confidentiality of any information we hold about you. For further information visit the following page: Confidential Information about You.

If you or your carer needs information about your health and wellbeing and about your care and treatment in a different format, such as large print, braille or audio, due to disability, impairment or sensory loss, please advise a member of staff and this can be arranged.