Real-World Anti-VEGF Treatment Experience Study in nAMD
Research type
Research Study
Full title
Real-World Anti-VEGF Treatment Experience Study of the Management of Neovascular Age-Related Macular Degeneration in the UK (RATE Study in nAMD)
IRAS ID
279984
Contact name
Louise Downey
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 4 months, 1 days
Research summary
This is a multi-centre, retrospective, mixed methodology non-interventional study to describe the clinical care endpoints, treatment patterns and real-world anti-VEGF therapy outcomes of patients with neovascular age-related macular degeneration (nAMD) in the UK. The study includes a retrospective medical record review, additional retrospective independent interpretation of medical imaging results and a service mapping survey, in patients who have been diagnosed with nAMD and who received anti-VEGF treatment in the UK.
Age-related macular degeneration (AMD) is the leading cause of blindness in the UK. The ‘wet’ form of AMD, also known as nAMD, is characterized by new blood vessel growth and if untreated results in progressive loss of central vision.
Anibizumab and aflibercept are the standard of care agents for treating nAMD in the UK. Treatment is administered by injection into the eye, usually monthly until maximum visual acuity is achieved. Subsequent treatment is determined from regular monitoring at clinic visits and follow up assessments.
The rigorous strategies recommended from the clinical trials of anti-VEGF agents are difficult to replicate in clinical practice, as they impose significant burden on patients, healthcare professionals and service providers.There has been limited research investigating the wider use of anti-VEGF treatment and associated clinical outcomes within real-world clinical practice in the UK and therefore the current study is designed to:
(i) Describe the real world impact of licensed anti-VEGF therapies on disease control
(ii) Survey the time interval between injections and planned monitoring schedules
(iii) Understand the type and format of the UK clinic service used for the management of patients with nAMD.The study will review 300 patient records at up to 30 UK centres, for patients newly started on anti-VEGF therapy. Records will be reviewed for up to 24 months from treatment initiation. A member of NHS staff will complete the service mapping survey for each centre.
Summary of study results:
What was the goal of this observational study?
In this observational study, researchers reviewed medical records from participants with neovascular age-related macular degeneration (nAMD). The goal of this observational study was to learn about the effects of 2 approved anti-VEGF treatments for nAMD in the United Kingdom (UK). This study looked at the effects the treatments had on the amount of retinal fluid and safety (medical problems known to happen with anti-VEGF treatments and nAMD). The 2 approved anti-VEGF treatments are aflibercept and ranibizumab. Participants received their treatments as part of their regular health care. This observational study started in July 2020 when researchers partnered with 17 National Health Service (NHS) hospitals in the United Kingdom. Researchers looked at medical records from 331 participants with nAMD who began receiving anti-VEGF treatments in 2017. The study ended in October 2021 when researchers finished collecting data from participants’ medical records.
What is neovascular age-related macular degeneration (nAMD)?
Neovascular age-related macular degeneration (nAMD) is a long-lasting eye disease that can cause blurred vision or vision loss, typically in people over age 50. nAMD is caused by abnormal blood vessels that leak blood or fluid into the macula.
The macula is the part of the retina that is key to seeing fine details clearly. The retina is the clear part at the back of the eye that is sensitive to light. Retinal fluid is fluid in or under the retina from leaking blood vessels in the macula. Retinal fluid can cause blurry vision or vision loss. In nAMD, high levels of a protein called vascular endothelial growth factor, or VEGF, cause abnormal blood vessels to grow in the eye. VEGF is a protein that helps new blood vessels grow when needed.
What are the anti-VEGF treatments approved in the UK?
Anti-VEGF treatments are a group of drugs, including aflibercept (a-fli-ber-sept) and ranibizumab (ra-nih-bi-zoo-mab), that are approved in the United Kingdom to treat nAMD. Anti-VEGF treatments block VEGF to slow the growth of abnormal blood vessels in the eye. This slows or stops damage to the macula and slows down vision loss. Anti-VEGF treatments are given as injections into the eye once a month for 3 months, and then as needed.
What were the results of this study?
Out of 331 participants in this study:
- 194 participants received aflibercept
•-137 participants received ranibizumab
Participants’ ages ranged from 54 to 99 years. Their average age was 79 years. There were
200 women and 131 men.
The researchers found that:
-Almost half of the participants (46%) had no fuid in or under their retina 1 year after starting anti-VEGF treatment.
-Less than half of the participants {41%) had no fluid in or under their retina 2 years after starting anti-VEGF treatment -Participants received anti-VEGF treatment an average of 7 days after being diagnosed with nAMD. Most received treatment about 2 days after being diagnosed and the longest was 57 days after being diagnosed.
-Most participants (96%) received at least 3 anti-VEGF treatments within 3 months of being diagnosed.
-Most participants (75%) had medical problems known to happen with anti-VEGF treatments and nAMD. The most common was loss of vision for fine details (worsening of visual acuity).This study helped researchers learn how the anti-VEGF treatments aflibercept and ranibizumab work and how they are given to people with nAMD in the real world. As new anti-VEGF treatments become available in the United Kingdom, researchers can compare their results to those from this study.
Where can I learn more about this study?
More information about the results and medical problems in this study can be found in the scientific summary of the results available on the Novartis Clinical Trial Results website (https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novctrd.com%2F&data=05%7C01%7Cbloomsbury.rec%40hra.nhs.uk%7C067c8cb864974961fc0b08db7c6ff295%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638240592472078557%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3x3DDmdHU95cIkOoXSmUYKB5Tk9KtkDOucy%2BMPbsQAs%3D&reserved=0).
Full clinical study title: Real-World Anti-VEGF Treatment Experience Study of the Management of Neovascular Age-Related Macular Degeneration (nAMD) in the UK (RATE Study in nAMD)REC name
London - Bloomsbury Research Ethics Committee
REC reference
20/LO/0461
Date of REC Opinion
1 May 2020
REC opinion
Further Information Favourable Opinion