The DANA Study
Research type
Research Study
Full title
Defining Disease Activity in Neovascular Age-related Macular Degeneration with Optical Coherence Tomography Angiography – A Prospective, Imaging Study – The DANA study
IRAS ID
263877
Contact name
Praveen Patel
Contact email
Sponsor organisation
Moorfields Eye Hosptial
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Summary of Research
This study is to find out whether using an extra type of scan called Optical Coherence Tomography Angiography (“OCTA”) will help to find new information to help doctors understand when to continue with eye injections and when it might be safe to stop treatment. This scan helps assess blood flow in the area of wet Age Related Macular Degeneration. This is particularly important as doctors want to minimise the number of eye injections wet AMD patients need so that side-effects of the injections are kept to a minimum.\nA total number of 150 eligible patients will be selected to join the study and images will be taken at two visits approximately six months apart.\nPatients will be selected from our internal register of potential subjects who meet the pre-screening inclusion criteria. These patients would have previously specified that they are happy to be contacted for research purposes. We anticipate that it will take 18 months to recruit our desired sample size of 150 patients. Patients will be in follow up for a period of six months. The study will conclude when the final patient visit has occurred.
Summary of Results
Background Imagine your eye has a special part called the macula, which helps you see clearly, like when you're looking at a book or a friend's face. Sometimes, tiny, unwanted new blood vessels can grow there. This is like having little weeds growing in a garden where you want pretty flowers. When these "weeds" grow, they can make your vision blurry.
Doctors have medicine that can help stop these "weeds" from growing. This study wanted to use a special camera, like a super-duper flashlight for your eye, to look closely at these blood vessels even after they've been treated. They wanted to see if the "weeds" were still there, even if they weren't causing problems anymore.What We Did
We looked at the eyes of 32 people who had these tiny blood vessels and were getting medicine to keep them under control. These people were getting their medicine every 12 weeks. We used that special camera (the "super-duper flashlight") to take pictures of their eyes.What We Found
Good news! None of the people had any new bleeding in their eyes, which is a sign that the "weeds" are causing trouble.
When we looked at the pictures, we could see the tiny blood vessels in almost everyone. Most of the time, these vessels still had blood flowing through them, even though they weren't causing problems. It was like the "weeds" were still there, but they weren't growing wild anymore.
We also saw that these "weeds" often looked like they were "mature" or older, like grown-up plants rather than brand new sprouts. Sometimes they looked like a tangled ball of yarn, or a dead tree. Some had a little circle around them (a "halo") or a main "pipe" bringing blood to them. Only one person had tiny new "branches" growing off the main vessel.What It Means
Even when doctors treat these tiny blood vessels and they seem calm, the special camera can still see blood flowing in most of them. This tells us that even if they're not causing problems right now, they're still there. It's like the "weeds" are sleeping, but they're still in the garden! This helps doctors understand more about these tiny blood vessels and how to keep your eyes healthy.Here's a more serious version for a UK adult with no medical knowledge and a reading age of 13:
Background
Our eyes have a crucial part called the macula, which is vital for sharp, detailed vision – the kind you need for reading, recognising faces, or watching television. In a condition called wet age-related macular degeneration (wet AMD), abnormal, fragile blood vessels can grow under this macula. These vessels cause problems because they can leak fluid or blood, leading to blurred vision and, if left untreated, this leads to vision loss.
Fortunately, there are effective treatments available, such as injections, that aim to stabilise these abnormal vessels. This study aimed to use a highly advanced imaging technique called Optical Coherence Tomography Angiography (OCTA) to closely examine the features of these abnormal blood vessels in patients who were already receiving treatment and whose condition appeared stable. The goal was to understand what these vessels look like at a microscopic level, even when they aren't actively causing new problems.Methods
We included 32 patients (one eye per patient) with wet AMD in this observational study. All these patients were receiving a standard treatment called aflibercept, given on a "treat-and-extend" schedule, meaning the time between injections was gradually lengthened as long as their condition remained stable. Specifically, these patients were attending a routine appointment where their treatment interval had been extended to 12 weeks. At this visit, we used the special OCTA imaging device to capture detailed pictures of the blood vessels in their macula.Results
Encouragingly, at the time of their 12-week check-up, none of the patients showed any signs of new bleeding in their macula or other indicators of active disease when examined with standard imaging. This confirmed that, from a clinical perspective, their condition was stable.
We were able to get clear, usable OCTA images from 31 out of the 32 patients. Our findings revealed that the abnormal blood vessel networks, on average, covered an area of about 3.6 square millimetres. Significantly, in 27 out of 31 patients (87.1%), we could still detect blood flow within these abnormal vessels, even though the condition was stable.
Furthermore, in almost all cases – 29 out of 31 patients (93.5%) – these abnormal vessels displayed features indicating they were "mature" or well-established, rather than newly forming.Conclusions
This study demonstrates that even in the majority of patients with well-controlled and stable wet AMD who are on extended treatment intervals, blood flow within the abnormal macular neovascularisation is still detectable using OCTA. These findings provide valuable insights into the ongoing nature of these abnormal blood vessels, even when the disease is clinically stable, and can help inform future treatment strategies.REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0114
Date of REC Opinion
26 Jun 2019
REC opinion
Favourable Opinion