A clinical trial could help determine the best treatment methods for a rare complication of wet age-related macular degeneration (AMD). Fight for Sight spoke to Professor Timothy Jackson, who is leading the trial, which we’re helping to support
Abnormal new blood vessels in the retina (the light-sensitive tissue at the back of the eye) cause wet AMD; these unhealthy vessels can leak blood or fluids (hence, ‘wet’).
Left untreated, the damage and vision loss caused by their growth is usually permanent.
Macular haemorrhage, or bleeding, is a rare but serious complication of wet AMD, and there are various treatment options available. The trial will help us understand which works best and which could lead to better outcomes, with the best interest of the patients in mind.
“Patients’ vision often goes down very suddenly, so if you can do something to help, we would all want to.”
Recruitment targets for the clinical trial
When asked why this trial is important, clinical lead, Professor Timothy Jackson, said: “One consultant might treat five or 10 patients over their career, so it is very hard to generalise from that and come up with any great wisdom. So, we don’t know how best to treat these patients, creating a substantial unmet need for more information.”
Supported by EURETINA, the European Society of Retina Specialists, and Fight for Sight, the study aims to recruit over 200 participants across the UK and Europe.
The trial will explore two interventions for sub-macular haemorrhage in wet-AMD:
- Injecting only medication called “anti-VEGF” into a patient’s eye is a standard treatment for wet-AMD, which relies on the cells in the eye clearing the blood away.
- Surgical intervention: an operation to inject the clot-busting drug into the bleed, which fills the eye with gas, followed by regular anti-VEGF injections.
Professor Jackson and his team have experience researching AMD and a keen interest in surgical interventions. So, when the opportunity arose to apply and run such a trial, Professor Jackson eagerly submitted a proposal.
“Some patients may not even be eligible for anti-VEGF injections [due to NICE guidelines]. Their vision often goes down very suddenly, so if you can do something to help, we would all want to.”
“Patients’ vision often goes down very suddenly, so if you can do something to help, we would all want to.”
Discover more about Age-related Macular degeneration in our A to Z of eye conditions.
Trials and tribulations: overcoming barriers to research
However, unexpected circumstances mean that the path of the trial hasn’t always been smooth. Professor Jackson has been hit by what he describes as a ‘perfect storm’ of issues.
“We had some major challenges. Brexit was a big issue for us. The trial is being run out of the UK but is pan-European. Now that we are out of the UK regulatory framework, we are effectively a third party, which means building another infrastructure layer,” he said.
Since then, the EU regulatory framework changed, bringing further challenges. Professor Jackson describes it as a ‘root and branch’ change in getting trial approvals. He said: “Doing trials is incredibly bureaucratic. The system was paralysed and in a state of shock for several months after it happened, where nobody knew how the new system would work.”
The team has also faced global drug shortages of the clot-busting drug, which they inject into patients’ eyes, and which is typically used to treat stroke.
“There is a global supply problem, and that makes for difficult decisions because if a unit only has a certain amount of drug, they’ve got to decide whether to allocate that to someone with an eye problem or a stroke.” said Professor Jackson.
On top of that, the COVID-19 pandemic hit its heights just as the trial was approved.
Looking to the future, what’s next?
Professor Jackson said: “Any of those things on its own would be a significant challenge but having all happen within one trial was exhausting – it is always at the back of your mind how many patients you have recruited in any week.” But recruitment has picked up. “We’ve got 30 sites, [and] 120 participants out of 210. So, we’re past the halfway mark.
The team is launching sites in Poland, Switzerland, Ireland, and Germany, and a Spanish site may follow. Given the rare nature of the condition, recruitment may take several months. However, the hope is that when complete, the statistics will show the best standard of care for people experiencing haemorrhage because of wet AMD.
“If you show that surgery isn’t helpful, then good. We don’t need to put people through surgery [or] if we show that surgery is beneficial, we know that everybody should be offered it. So, either way, the result will be of value,” says Professor Jackson.
