• Lucentis, Macugen, Avastin
• Current protocols
• Anchor study..classic CNV
• Marina study...occult CNV
• Anecortave acetate
• A flow chart
• IVT (intravitreal triamcinlone)..discussed on sister site
• Intravitreal injection of Lucentis, Macugen, Avastin
  


• risks
• hours
• days
• pregnancy
• anticoagulents
  
  
• links NEJM in minimally classic/occult ARMD, and in classic
• Action for ARMD Treatment  if your Primary Care Trust refuse funding
• NICE Guidelines

These drugs which are given as injections into the vitreous cavity of the eye see. They are very effective treating most types of wet ARMD.

They are anti-growth factor drugs, and work by preventing the growth factor VEGF from working. VEGF stimulates the growth of the 'new blood vessels' involved in neovascular ARMD, so when its effect is blocked the vessels close and the leakage stops. The VEGF is released from damaged retina.

NICE have announced in provisional guidleines that Lucentis will be funded in the next few months. This is for both classic and occult wet-armd.

Research suggests Lucentis is the most effective. Macugen is less effective, and both have been approved by the FDA. Macugen . These drugs may be more effective if used in combination with PDT.

Many ophthalmologisst believe that Avastin (Moorfields)  is just as effective as Lucentis, either but it has to be given 'off label' in the UK; both are now approved in the US, but only Lucentis is licensed for use in the UK.Avastin is much cheaper than Lucentis, and is made by the same company. All the research has been carried out with Lucentis, not Avastin. It is likely that this is because the company has a conflict of interests, and there is much less profit to be made from Avastin. The company is withdrawing cheap Avastin from the US making it difficult for ophthalmologists to use.

Avastin is safe    studies of avastin   for a RAP    CNV ARMD    more studies   Avastin for CNV     Myopic CNV

The benefits of Lucentis (Ranibizumab) are described in October 2006's NEJM in minimally classic/occult ARMD, and in classic . The financial aspects, and the debate as to whether ranibizumab (Lucentis) and bevacizumab (Avastin) are most effective, is discussed here . An audio interview is here.

Although these drugs are effective, 'dry' macula' changes still progress after treatment and sight can slowly deteriorate over years.

1. Assess all patients eligible with FFA
   
   
2. the best-corrected visual acuity is between 6/12 and 6/96
   
   
3. there is no permanent structural damage to the central fovea
   
   
4. lesion size is less than or equal to 12 disc areas in greatest linear dimension
   
   
5. there is evidence of recent presumed disease progression (blood vessel growth, as indicated by fluorescein angiography, or recent visual acuity changes)
   
   
6. Lucentis injections monthly for 3 months see
   
   
7. assess with OCT at future visits..treat whenever there is a 100 micron increase in retinal thickness in foveal area.
   
   
8. after 3 injections a 1 month check, if inactive may extend the next check from 4 to 6 months
   
   
9. and so on...extending the intervals a few weeks if the condition remains inactive
   
   
10. PDT or intravitreal steroids may be needed for certain cases
    
    
11. treatment this improves sight in 40%
    
    
12. another 50% 'will stabilise', but the sight may get 3 lines worse.
    
    
13. the remaining 10% get much worse (particularly if smoking continues)
    
    
14. 'classic' neovascular ARMD' responds much better.
    
    
15. 'occult' neovascular ARMD, type 1' with a PED responds the worse, and occasionally the retina may 'rip', but they are still moderately effective. See the Marina study.
    
    
16. They will also be effective against 'occult' neovascular ARMD, type 2 (without a pigment epithelial detachment). It is expected NICE will groups classic and occult CNV together
    
    
17. Prior to NICE has approved Lucentis treatment, and Primary Care Trusts have 3 months to make the service available
    
    
18. Risk factors must be addressed....smoking (stopped), blood pressure (low, <140/80), little salt, little transfats and saturated fat, a low cholesterol (helpful..consider statins), oily fish (twice/week), 5-9 portions vegetables/fruit a day (ie 2 salads and 4 fruits...vitamin tablets if this is not possible), exercise (walking/dancing/gardening 60 minutes/day, longer if overweight). Relations should take similar precautions.
    
    
19. the Anchor and Marina study used monthly injections (Lucentis). Alternatively, without PDT.
    But the Pronto study, after the first 3 months of loading injections, involved monitoring progress and only gave repeat injections if their was a recurrence. A suggested regime would based on this,
    .....that is 3 x monthly injections for 3 months
    .....after that repeat injection if 5 letters were lost, or if OCT showed more than 100micron thickening;
    ...... or if there was haemorrhge present.
    In this way, based on the Pronto study, only 5 injections would be necessary (on average 5 in the first year. (After the first year, results are unclear). The Pronto study did not use PDT.
    
    
20. Lucentis/Avastin treatment is far superior to no treatment or PDT alone for most patients.
    
    
21. The PIER study treated at 0, 1, 2, 5, 8, 11 months...but results were not as good as ANCHOR.
    
    
22. ranibizumab should be continued only in people who maintain adequate response to therapy. Criteria for discontinuation should include persistent deterioration in visual acuity and identification of anatomical changes in the retina that indicate inadequate response to therapy. It is recommended that a national protocol specifying criteria for discontinuation is developed.
    
    
23. Pegaptanib is not recommended for the treatment of wet age-related macular degeneration. (NICE)

Anchor is is the main Lucentis and classic CNV study.

Marina is is the main Luentis and occult CNV study.

• Abstract
• Aisenbrey's study.

The procedure is discussed here. (Triamcinolone has extra risks and is discussed here.) In ARMD or CNV they are usually given in addition to PDT. These drugs are not yet available for general NHS use. Avastin,  Macugen ,   infection..preventing

These drugs are given as an injection into the vitreous cavity of your eye. They are given in a clean room or an operating theatre. The injection procedure itself takes seconds and is usually feels like a tiny prick. You can go home later that day...this is a 'day case' procedure'.

After the injection you usually notice black swirls in the vision, which start to disperse gradually, but are a nuisance for a few weeks. By one month the drug should be working.

About 1/1000 people will develop a serious eye infection.

The day after the injection your eye should be comfortable. If your eye starts to get red, with misty vision (there may be no pain), perhaps 2-5 days after the injection, you should suspect an infection and attend your eye department urgently. In Birmingham this is the Birmingham and Midland Eye Centre Casualty  at the Birmingham & Midland Eye Centre, City Hospital, Dudley Road, Birmingham B18 7QH
Tel: 0121-554 3801 evenings