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Treatment options for Wet Macular Degeneration

The first point of contact for treatment options should be with your eye specialist. In many cases this will be a retinal
specialist. You should always discuss any concerns, questions or information you have obtained with your specialist. The specialist is in the best position to advise you on your treatment options.

Wet Macular Degeneration (MD) occurs when abnormal blood vessels grow and leak into the retina. This process is called neo-vascularization (CNV). Neo = new and vascularisation = vessel formation.

There are currently two sections of treatments available for people with wet MD:
  • Treatments proven to be effective by controlled trials published in peer review journals
  • Experimental treatments
The treatments are not curative and aim to keep the best vision for as long as possible.
TREATMENTS PROVEN TO BE EFFECTIVE BY CONTROLLED TRIALS published in peer review journals
The blood vessels caused by Wet MD are prompted to grow by a protein called Vascular Endothelial Growth Factor (VEGF). Unfortunately this is not a good thing in MD as the new blood vessels damage the retina. This results in the loss of central vision. New drugs, called anti-VEGF drugs, are used to stop the growth of these blood vessels.
 
1. Lucentis (ranibizumab)
Lucentis is an anti-VEGF drug which is injected into the eye (into the vitreous) at 4 week intervals. The one-year results of two separate trials have been published and show this treatment is extraordinarily effective. Roughly 7 to 8/10 patients maintain their vision or notice improvement. Over one third still have vision in the affected eye that would enable them to legally drive a car.
Lucentis appears to be equally effective for all the types of Wet MD and for all lesion sizes.
This treatment is registered under the TGA (Therapeutic Goods Administration). Patients should discuss details of the injections with their doctor. Lucentis is currently in Phase 3 trials in Australia, looking at varying the frequency of administration and using it in combination with PDT.

2. Macugen (pegaptanib)
Macugen, like Lucentis, is an anti-VEGF drug that is injected into the eye (into the vitreous) at six week intervals. The vitreous is the jelly-like substance that fills the eyeball. Macugen has not been shown to be as effective as Lucentis.
Macugen has undergone phase 3 trials and has been shown to be as effective as PDT. However, similar to PDT, it has not been shown to be effective in either large occult or minimally classic lesions. There are two types of new vessels (CNV) seen in Wet MD. One is clearly delineated by fluorescein angiography and is called classic; the other is difficult to see clearly and is called occult or hidden.
There has been limited availability of Macugen under a special access scheme but this has now ceased for new patients.
3. Photodynamic Therapy (PDT) / Visudyne Therapy
This is a two step process combining a light sensitive drug (Visudyne) and the light from a non-thermal laser directed on to the retina. The chemical reaction between the laser and the drug causes the blood vessel to close off.
The treatment does not cause direct damage to the surrounding retina. It therefore can be used to treat new vessels that are under the centre of vision. PDT is effective in the classic type of lesions regardless of size. PDT is also effective in small occult lesions but not large ones.
PDT is a course of therapy and several treatments are needed to keep the leaking blood vessels closed and stop the progression of Wet MD. Close follow up and monitoring with the attending eye doctor is needed to determine if further treatment is required. Unlike Lucentis (in which the vision is usually maintained), patients having PDT continue to lose vision in the first six months. Their vision then stabilizes so that the eye does not go on to severe vision loss.

4. Laser Photocoagulation
This treatment consists of a concentrated light beam of high energy, thermal light is directed on to the retina to destroy and seal the leaky blood vessels. A contact lens is placed onto the eye. The doctor will give instructions on where to look, so that the eye remains still while the laser is focused on the area being treated at the back of the eye. The laser seals and destroys the blood vessel. This is not a painful procedure.
The laser not only destroys the new vessel (CNV) but also destroys the area of retina involved with the new vessel. Therefore it can only be used for treating new vessels that are not under the centre of vision. This is only a small percentage of patients who present with Wet MD. Close follow up and monitoring with the attending eye doctor is needed to determine if further treatment is required, as there is a 50% recurrence rate.

5. Retaane (anecortave acetate)
This drug is an angiostatic drug that inhibits the abnormal growth of blood vessels. Angiostatic cortisenes are derived from the steroid class and are made to remove chemical groups responsible for side effects, such as the development of cataracts and elevated intraocular pressure leading to glaucoma, while preserving potency against
angiogenesis.
This drug is administered through a tube called a cannula that is inserted behind the eye. The drug is deposited at the back of the eyeball. It needs to be repeated every six months to maintain efficacy. The treatment appears to be as effective as PDT for lesions which contain some classic component. There are phase 3 trials being recruited looking at Retaane being used in conjunction with one of the anti-VEGF drugs.
It has now been approved for use in Australia but no funding is available. The cost of the drug is $1800 and does not include the cost of the procedure.

EXPERIMENTAL TREATMENTS
1. Avastin (bevacizumab)
Avastin is an anti-VEGF drug, like Lucentis, that is injected into the eye (into the vitreous). It was not designed for use in the eye and was produced and approved for the treatment of colorectal cancer.
Avastin has been used worldwide in the past one to two years for treating patients with Wet MD. A number of case reports suggest that it is highly effective, but it remains unproven with regards to both safety and effeciency. Like Lucentis, it appears that Avastin needs to be injected repeatedly to maintain its effect. It is still not clear as to how often the injection should be given.
2. Triamcinalone (Kenacort)
A slow release steroid designed for injection into joints, has been used ‘off label’ by some retinal specialists to
supplement CNV treatments particularly PDT. It seems to have a beneficial effect when used in conjunction with PDT but has been shown in a controlled trial to be ineffective as a sole treatment. It is injected into the eye but has been shown to promote cataract formation and in a third of patients to increase the intraocular pressure often necessitating glaucoma treatment. The effect of one injection lasts a few months. Side effects increase with repeated injections.

3. Evizon (squalamine lactate)
Evison is given intravenously, eliminating the risk of infection and injury to the eye associated with intra vitreal injections. It is the first clinical drug candidate in a class of naturally occurring, pharmacologically active, small molecules known as amino sterols. It has a unique multi-faceted mechanism of action that blocks the action of a number of angiogenic growth factors, including vascular endothelial growth factor (VEGF), cytoskeleton and integrin
expression.
It has not gone beyond phase 2 studies. There has been no explanation of the delay in starting phase 3 studies.
Updated 10 April 2007 - Any decisions made about treatment options for Wet Macular Degeneration should be made in consultation with your ophthalmologist.
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