Newsletter Winter 2012

Dear patients and friends,

Apologies in advance, this newsletter is about 2 months overdue, but better late than never. Whilst I blame this on my ever-increasing clinical commitments, we have also recently gone through a major merger in my nhs trust (Whipps Cross University Hospital) and have now become part of Barts Health. I have also increased my research commitments and with revalidation and appraisal an ever more important part of the way we practice, time seems to have just disappeared. The conference season is usually less onerous during the period December to February, so I thought I should dedicate this newsletter to give you an overview of the major published articles in the retinal literature in the last 18 months. What did we learn and how does this affect our patient management. Finally, what does NICE say about these new treatments and ideas? I will also sneak in a brief summary of the “implantable miniature telescope” for patients with advanced macular degeneration and my recent application to introduce this new development at Barts Health.

As usual, if you have any specific requests, please let me know! I do hope you enjoy the newsletters and I look forwards to hearing from you.

Hadi Zambarakji MB ChB, FRCOphth, D.M
info@retinacare.org.uk
Spire Roding Hospital, Roding Lane South, Ilford. IG4 5PZ.

Ranibizumab (Lucentis) for Branch and Central Retinal Vein Occlusions

The reports details follow up data from the BRAVO and CRUSE trials, both of which showed benefit for the use of Lucentis up to 6 months. We now learn from these follow up reports that ongoing injections will be needed for most patients beyond 6 months, and that patients who had been given sham injections as part of the trial (first 6 months) do respond when treated 6 months after presentation, but their response is not as extensive. We do not know if scheduled monthly injections would be superior nor do we know how many injections and how long beyond 12 months we should be treating. However, prolonged delay of treatment after presentation would seem unwise.

Age Related Macular degeneration (AMD)

We have learned that from the CATT trial one and two year data that Ranibizumab (Lucentis)  and Bevacizumab (Avastin) have equivalent effects when the dosing regimens are the same. Broadly speaking, patients with wet AMD treated with monthly injections tend to do slightly better than those treated with less frequent injections (please see the summary on my web site on http://www.retinacare.org.uk/pdfs/Intravitreal_injections.pdf).

Cataract and AMD often co-exist and this issue is therefore of great clinical relevance. It was reassuring to learn that patients who receive Lucentis treatment for wet AMD and underwent cataract surgery seemed to do as well as the control group. In the absence of prospective data, we can therefore conclude that it is reasonable to consider cataract surgery in patients with AMD. It remains unclear however where in the injection cycle (ie the cycle of Lucentis treatment) should we consider cataract surgery.

Eylea (Aflibercept):Aflibercept (previously called VEGF trap) is a decoy receptor protein, which binds to VEGF with much greater affinity that Lucentis or Avastin. Most efficacious therapies for wet AMD of course, are based on the inhibition of VEGF (vascular endothelial growth factor), which when down-regulated results in the inhibition of wet AMD and improvement in vision.  We have now learned from the VIEW trials that Eylea given monthly or 2 monthly after 3 initial loading doses produces similar efficacy and safety outcomes as Lucentis monthly treatment. This is a very exciting development, as the 2-monthly regimen would reduce the potential risk and burden of monthly injections. The FDA approved and recommended the 2 mg dose every 2 months in August 2012 and the drug received marketing authorization in Europe in November 2012.

Implantable miniature telescope for advanced macular degeneration:

Some patients with advanced macular degeneration in both eyes (when injections are no longer able to help) may benefit from the insertion of a telescopic implant in one eye only. The telescope implant, which is based on the principles of a Galilean telescope, enlarges the view in front of the eye by approximately 3 times. This helps reduce the ‘blind spot’ and allows the patient to distinguish and discern images that have been unrecognisable. The telescope is implanted in one eye of patients with bilateral end-stage AMD. Improved central vision in the implant eye is effectively combined (by the brain) with the peripheral vision in the non-implant eye, thereby improving the patient’s overall vision. NICE recommends that this procedure should only be used with special arrangements with clinical governance, consent, audit or research. In other words, if a unit is set up to perform this surgery, there needs to be clear audit of outcomes and patients should be completely aware of the guarded benefits and the limitations of the procedure as well as the possible risks of surgery. I think this is an interesting procedure with potential benefit and I have recently submitted an application to Barts Health and awaiting a response. If this is positive, I will then need to approach the commissioners to achieve local funding for this. I will keep you informed of any progress in future letters.

Vitreomacular adhesion (VMA)

VMA is a condition where the vitreous gel adheres to the retina in an abnormally strong manner and results in traction on the retina, sometimes resulting in a macular hole or an epiretinal membrane. Jetrea (Ocriplasmin) is a drug which, when injected in the vitreous cavity, results in clean separation of the vitreous from the surface of the retina. This is a major advance and gives us the option of treating some patients with VMA pharmacologically (ie with an injection into the vitreous cavity) rather than with vitrectomy surgery. Jetrea is FDA approved so currently in use in the USA, and the European Medicines Agency has recently recommended the approval of Jetrea in Europe (Jan 2013). It is therefore very likely that marketing authorization in Europe will be available reasonably soon. What the data we have so far shows is that Jetrea results in resolution in VMA in 30% of eyes compared to 10% in those given a sham injection. The data also shows that patients with small macular holes have a 60% closure rate. This is clearly a major advance and means that fewer patients with macular holes will need vitrectomy surgery.

Diabetic macular oedema (DMO)

NICE has now approved the use of Lucentis for patients with DMO when the central retinal thickness is 400 microns or more at the start of treatment. NICE also recommends that patients currently receiving Lucentis for DMO should be able to continue treatment until their clinician consider it appropriate to stop. Another interesting therapy for DMO is steroids. Ten years ago we used intravitreal triamcinolone and for various reasons, the majority of medical retina specialists seldom use this drug. Alimera Sciences have developed the Fluocinolone implant (Iluvien) as an alternative treatment option for DMO. The advantage of this implant is that it can deliver small amounts of steroids into the vitreal cavity over a long period of time. Visual benefits are greater with the implant compared to the “standard of care” (ie vs. laser or observation), but I am not aware of a head to head comparison Iluvien vs. Lucentis therapy. NICE however does not recommend the Iluvien implant for DMO at this stage, bearing in mind a number of facts including a 60% risk of developing high intraocular pressure, a 30% of needing surgery to control the intraocular pressure, and that nearly all phakic patients will develop a visually significant cataract as well as the cost of this implant at £5,500 plus vat.

I hope this was of interest to all of you, and I will try to keep you all stimulated and interested by sending you more regular updates. Finally, in my last letter I said “it is clearly time to include more common anterior segment topics and this will feature in my next newsletter early in the New Year”, so I promise cataracts are next!

Hadi Zambarakji

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