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IN TOUCH

TX:Ìý 26.03.2024Ìý 2040-2100

PRESENTER:Ìý ÌýÌýÌýÌýÌýÌýÌýÌý PETER WHITE

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PRODUCER:ÌýÌýÌýÌýÌýÌýÌýÌýÌýÌýÌý BETH HEMMINGS

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Actuality clip

Practitioner

You need to put your chin on the end and head right across the bar.Ìý Now the headrest has a sensor on it.Ìý Now there’s four phases on each eye.Ìý The first phase is an orange flashing light – that’s what you need to concentrate on, you can keep both eyes open, you can blink.Ìý The red one is a heat sensor, so very, very bright.Ìý You close your eyes on that one…

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Patient

Do phase one and phase two do one eye and phase two and phase three do the other eye?

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Practioner

Yeah.

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Patient

Okay.

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White

Age related macular degeneration or AMD is the most common cause of vision loss in the UK, affecting somewhere around 700,000 people.Ìý There are two types – wet and dry AMD – and until now, people with dry AMD have had to be told there’s no effective treatment.Ìý So, it’s not surprising that when the claim was made that there is now a treatment which can slow and, in some cases, reverse the loss of vision, there’s been a flurry of excitement.Ìý But it is very early days, so it’s also not surprising that there are quite a lot of questions about it being asked and some scepticism.

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Well, I’m at the Optegra independent hospital in Manchester.Ìý The consultant ophthalmic surgeon I’m with is Sajid Mahmood, who has been offering this treatment, known as valeda light therapy since the beginning of the year.Ìý We’ll be talking to him in a moment but first of all, we’ve been allowed to eavesdrop as a patient receives the treatment.

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Actuality – treatment for dry AMD

Practitioner

Right, I’m just going to line you up, make sure the light’s in the correct position.Ìý That’s fine.Ìý Are you ready to go?

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Patient

Yeah.

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Practioner

Off we go.Ìý This is the 30 second phase and if you concentrate on that orange light for me.Ìý Okay, that one’s done.Ìý Are you ready for the second one?Ìý Eyes closed for me.Ìý A minute and a half on this one.Ìý This is the heat sensor one.Ìý Okay.Ìý You’re done.

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Patient

That’s good, thank you.

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Practioner

Right, just hang on, get your vision back.

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White

Ophthalmic surgeon Sajid Mahmood, can you just explain what we’ve seen, what was actually happening there?

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Mahmood

Yes, you’ve just seen a patient having a treatment called photobiomodulation.Ìý And the principle is that the treatment delivers light wavelengths that have been shown to be beneficial in terms of cell function.Ìý With dry macular degeneration we’ve got cells that are starting to work less well, starting to lose their function and with this treatment we aim to help revive that function.Ìý The specific wavelengths that have been shown to be beneficial are the red and yellow light and the near infrared.Ìý So, you see a patient cycle through these beneficial wavelengths and the treatment lasts about five minutes per eye and they receive that in, what are called, treatment cycles.Ìý Each cycle involves attending the clinic for nine visits over a period of three to four weeks.Ìý And based on the studies behind the treatment the cycle needs to be repeated.Ìý The best results are from repeating that cycle three times a year.Ìý Patients have a condition in which over time they expect that there’ll be an ongoing deterioration.Ìý What we hope is that at least we will stabilise their eye for longer.

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Patient

The last couple of years I’ve noticed that my eyesight was declining and I mentioned that to my optician.Ìý They told me I had macular degeneration.Ìý I was advised, about a month ago, that I had the dry.Ìý So, I’ve tried to put in place a number of things that will hold back the symptoms of the decline.Ìý So, for example, looking at diet – taking supplements – and making sure that the glasses that you’ve got are appropriate in terms of the UV that is coming in to your eyes.Ìý So, I’m taking all of those sort of mitigating actions where I can but then I was advised that this new treatment is also available so to me it’s just another string in the bow, in the armoury, of trying to stave off the effects of degeneration.Ìý My eyesight’s very important to me with the things that I do in my life.Ìý I do an awful lot of conservation work and outside work with wildlife and do a lot of birdwatching and my ability to do that as a hobby is being restricted more and more all the time and I find that quite frustrating, to be honest with you.Ìý So, I just see it as something else that I’m doing that’s worth investing in.

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White

Can I ask you how much it will cost you?

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Patient

The treatment that we’re undergoing at the moment costs about £1,400-£1,600 somewhere like that for each series of treatments that you come to.Ìý I’m on my first round of treatment.Ìý I’ll look at the outcomes of that, I’ll look at the outcomes of the second round that I do and take a judgement from that point in time.

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White

Any noticeable effects yet on your sight?

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Patient

I’d love to say yes but it’s early days.

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Mahmood

This particular treatment, the studies started on it about seven years ago and it’s been available, actually, for longer, it’s been available now about five years.Ìý I personally held off introducing it until I felt that the evidence that was building was strong enough and I personally felt we’d reached that point that last year when the company published the third in its series of clinical trials on this.

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White

But it has been used elsewhere – I mean successfully?

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Mahmood

Successful trial results have been reported for the last five years and so the company will have had to have successful trial results to get its licence to actually commercialise it.Ìý And I know colleagues have been offering it on a small sort of ad hoc basis here and there for a number of years.Ìý But we’ll be monitoring this closely – we are imaging patients, we are monitoring their vision and we’ll audit our data to do this in a robust way.

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Treatment – actuality

Phil

Alright Trevor, so I’m Phil, I’ve never seen you before, okay, so I’m going to do your treatment for you today, alright?Ìý So, we’re going to get you lined up and it’s just your right eye we’re treating, is that correct?

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Trevor

It is.

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Phil

And it’s going to be your third treatment today?

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Trevor

It is.

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Phil

Okay, so, I’m just going to get everything into position now, alright?

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Trevor

Yeah, yeah.

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Phil

So, can you see that light there?

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Trevor

I certainly can.Ìý I don’t know it’s entirely to you, I don’t know whether the light should be marginally higher.

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Phil

It’s over your eye socket, so that’s fine now.

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Trevor

That’s fine, excellent.

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Phil

Alright, okay?

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Trevor

I’m not trying to teach you your job believe me.

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Phil

No that’s all good…

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Trevor

About two months ago, six weeks ago a very old friend, good friend of mine, said – By the way I’ve seen something in the paper, there’s now a treatment for macular.Ìý I said – You’re joking.Ìý He said – No.Ìý Anyway, they made an appointment, they came here and I said – Well, when you’re go, I said, find out what the treatment involves.Ìý And he came back and I said – Right, the first question I’ve got to ask you is whatever the treatment is or isn’t, if it doesn’t work can it do any permanent damage to your eye.Ìý If it’s 50/50 that it can improve it but it’s also 25% it might cause a problem I’m not interested, I said, but I’m happy to give something a go where there is no danger that’s it’s going to in any way detract from what I’ve got now.

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White

So, were you reassured that there is not risk involved?

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Trevor

Right, I can only tell you that initially the same questions were asked to the consultant here by my friend and it was in three stages.Ìý The first stage was that it can’t do any damage to the eye whatsoever.Ìý The next two stages are – if you have the treatment, one thing that they can almost certainly guarantee is for the period of time that you have it, your sight won’t go any worse and depending on the degree that the macular is etc. etc. etc. and the different way that eyes respond to treatment, it could well improve them, what percentage, how much, they’ve no idea, they really don’t know, it’s suck it and see, you might be one of the lucky ones and get your full sight back, you might get a 10% increase.Ìý The main thing, as far as I was concerned, is it would maintain its current status and I’d be able to continue to do exactly what I’m doing – play golf (not very well these days).Ìý And the consultant said – we can only look three to five years in advance.Ìý And I said – well, at 84 I ain’t looking above three to five years, so don’t worry about it.Ìý As far as I’m concerned, as long as it’s no worse, then it’s doing its job.

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Mahmood

So, as a ballpark I say to patients, based on the study data, if when you go to your optician you can read to around the middle of the chart or better and you’re affected by dry macular degeneration that’s probably the time when the treatment may give benefit to you.Ìý It’s unlikely to be beneficial if you’ve got severe vision loss due to dry macular degeneration and I’ve had to decline patients who’ve been enquiring and attending because I also want to be realistic, I would only offer the treatment if I felt it was going to be beneficial.

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White

Now it is very early days, as we keep saying, which is why there is some scepticism.Ìý What trials have been done and what’s the evidence that it works?

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Mahmood

So, the company has done clinical trials, which they call the Light Sight studies and in these trials they compared patients been given the treatment in a randomised way with patients who are given what’s called a sham form of the treatment.Ìý And they did Light Sight one, Light Sight two, Light sight three.Ìý Light Sight two was actually done in Europe and involved UK centres as well.Ìý The Light Sight three study is their biggest study and that was done in the USA, primarily.Ìý And the strength of it is that multiple centres were involved, reputable centres involved liked Stanford University, New York Eye and Ear, Duke University.Ìý They had the objective evidence, the imaging data analysed independently by the Duke University Reading Centre, high quality studies.Ìý And what they showed was that patients on the treatment versus patients without the treatment, on average, got about a line improvement on the sight test chart.Ìý But the objective data on the imaging results, this process where drusen is the waste material building up on the retina, the volume of drusen accumulation was less in patients who were on the treatment and the progression on to the late forms of dry macular degeneration was also less in patients on the treatment versus those without.

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White

But as you say, it’s not yet been adopted by NICE – the National Institute for Health and Care Excellence – and therefore it’s not available on the NHS yet.Ìý Do you understand why some people, including ophthalmologists, are a bit sceptical?

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Mahmood

I do understand that because I would consider myself in the same boat.Ìý When I heard about the treatment, a few years ago, I was very sceptical.Ìý Even knowing that colleagues who I respected were actually involved in the studies, I maintain my own scepticism, yeah I’m trying to be guarded about what we can expect, you know, it’s not a cure, it’s a way of hopefully keeping the cells functioning for longer, hopefully our patients will get an improvement but it’s early stages in our implementation of this here at Optegra.Ìý And the company has announced, this year, that they will be doing real world data collection exercise of the 500 to a thousand patients that have been treated.Ìý And all of this gives me more confidence that those who are behind the treatment are doing robust clinical studies and they’re also doing surveillance of its use in clinical practice.Ìý Long term, I think, even if there isn’t a significant improvement in vision, if it’s stabilised for longer, that’s still a success.

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White

Sajid Mahmood from Optegra independent hospital in Manchester.

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Well, I said there were sceptics, listening to our report from Optegra is one of them.Ìý Alex Foss is consultant ophthalmologist at Nottingham University Hospital Trust who specialises in medical retina and macular degeneration.Ìý

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Alex Foss, you’ve heard our report, still sceptical?

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Foss

Well, I’m afraid yes, there’s much what he said I agree with, certainly the safety profile I think looks very promising indeed but on the effective side, as you said, professional opinion is split.Ìý He referred to the Light Sight studies.Ìý Light Sight one was a small pilot study which included there was no evidence for an effect.Ìý Light Sight two study, he referred to, was rather inclusive, unfortunately I think it was done during covid so it failed to recruit large numbers.Ìý Their main evidence comes from Light Sight three.Ìý Looking at that data, there were a couple of points I would like to make.Ìý First, the trial had about a hundred patients and 148 eyes and they analysed the data as if each eye was independent and that would have the effect of underestimating uncertainty.Ìý Take a simple example – eye colour – if you get a right eye that’s coloured blue, well you can guess what the colour of the left eye might be, so not truly independent.Ìý Secondly, in the press release, they said 55% of the treated group had one line improvement but that’s not quite how a trail works.Ìý A trial you’d divide into two arms and you randomise them to either treatment or an intervention arm or to a control or sham arm and you prepare the outcome between these two arms.Ìý And in the trial 41% of the sham arm also improved by one line of vision, so the treatment sight effect is probably not huge.Ìý And the third point to make is that although there’s very small numbers in the treatment arm there was increased incidents of developing wet macular degeneration, about 5.4%, with the sham arm it was 1.8%.Ìý So, the views that I have of it is very interesting data, it certainly justifies further investigation but I don’t, personally, think it’s strong enough yet to recommend its routine adoption.

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White

I mean the way these tests are done are quite complicated to explain.Ìý If I understood you correctly, not all the factors in all the cases have been fully taken into account.Ìý I mean would that be fair?

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Foss

I think it’s fair to say there are still a number of unanswered questions about the data.Ìý It was very surprising to me and interesting, for example, the people in the sham arm got visual improvement, it’s not something I would have expected.

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White

And I mean how can that happen?Ìý I mean can people subjectively think that there’s been an improvement that there hasn’t been?

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Foss

Well, there’s the well known placebo effect.Ìý The tests they do, the vision tests, looking at the chart, almost like a psychophysical test and depends on how hard the patient tries, in fact they’ll see a bit better.Ìý But this is pure speculation.

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White

Right, so where are we?Ìý For example, clearly, this would be different if NICE had accepted this at this stage and it were available on the NHS.Ìý That hasn’t happened.Ìý We’ve asked for a statement from NICE, at the time of recording we’ve not had that, what would be your understanding of when that might happen, i.e. that NICE accepts that it’s safe and cost effective to use?

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Foss

Well, you’ve put your finger on it.Ìý First of all, there’s a big difference between the MHRA, the regulatory body, and NICE, who recommends.Ìý So, MHRA want to reassure themselves that it’s a. it’s safe and b. the performance – can it deliver [indistinct words] potential, the answer to both these questions is yes.Ìý NICE will be looking at questions like does it work, is it better than alternatives and is it cost effective.Ìý And for that you’ll need health technology assessment.

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White

Okay.Ìý Well also listening is Cathy Yelf, who is chief executive of the patient support group the Macular Society.Ìý I’m sure, up until now, you’ve also had to tell people that there’s been no effective treatment for dry AMD, if someone asks you for advice on this tomorrow, what would you tell them?

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Yelf

Well, what we say is that there is some limited evidence that it is effective and there is absolutely not evidence that it’s not safe.Ìý And if you can afford it and it doesn’t damage your other ability to spend on things that are essential in your life, then by all means try it.Ìý We would not dissuade people from trying it.Ìý But as is clear, it’s an expensive treatment, relatively expensive treatment of about £4-5,000 a year and, of course, the problem is that not many people can make that choice.Ìý So, it really depends on somebody’s ability to pay at the moment and the amount that they are able to invest in that limited data that’s available.Ìý So, I think from the three trials that have been published so far, fewer than a hundred patients in those trials altogether actually received a treatment.Ìý So, it’s quite a small sample of patients.Ìý Different people, as you heard, will have different responses to that – for some people that’s going to be enough to invest and for other people it’s not going to be.Ìý And what we want really is more evidence, so that it can go to NICE and therefore hopefully be available to everybody.Ìý If it works, we want it to be available to everybody.

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White

Because presumably it has been very frustrating for you to have to say to people so often, in the case of dry AMD, there’s really nothing we can do except maybe lifestyle changes.

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Yelf

Yeah, we would never say there’s nothing you can do, we’re allergic to the phrase – there’s nothing we can do.Ìý But certainly, there’s no proven medical treatment yet for macular degeneration that is available widely and free at the point of delivery, certainly in the UK.Ìý There are some treatments coming through now and some have been approved in the US, for example, but they’re not available here yet.Ìý And it is desperate for people, they really, really want to have a treatment for macular degeneration, of course they do, and that’s why how these are sold to people and the promises that they make are so very important.

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White

Cathy Yelf, Alex Foss, thank you both very much indeed.

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And that’s almost it for today.Ìý We’re always glad of your comments and experiences.Ìý So, on this or indeed anything else, you can email intouch@bbc.co.uk or leave your voice mails on 0161 8361338.Ìý And I should say that over the past few weeks we’ve been telling you about a change to the duration of the programme.Ìý Well after a review of the Radio 4 schedule I’m pleased to say that won’t be happening now, so it’s very much as you were.Ìý In Touch will be here every Tuesday evening – 8.40.Ìý And, as a bonus, you’ll be able to hear a repeat of the programme early on Sunday mornings.

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From me, Peter White, producer Beth Hemmings and studio manager Kelly Young, goodbye.

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