Intermediate AMD: development of novel clinical endpoints for clinical trials in patients with a regulatory and patient access intention


Start Date
End Date
IMI2 - Call 7
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
8 025 000
EFPIA in kind
8 083 500
110 418
Total Cost
16 218 918


People with dry age-related macular degeneration (AMD) gradually lose their central vision, usually in both eyes. It is already a leading cause of blindness worldwide, and as the population ages, the number of cases is likely to rise. There is currently no effective treatment for dry AMD. One barrier to the development of new treatments is the lack of tests capable of determining the effectiveness of treatments under development. Put simply, current tests do not detect all of the sight problems experienced by people with earlier stages of the disease (e.g. intermediate AMD).

The goal of the MACUSTAR project is to develop and validate tests that are capable of accurately detecting subtle changes in the disease over time. The project will follow more than 700 AMD patients over 3 years through tests including state-of-the-art imaging techniques and vision testing, as well as patient-reported outcome measures that capture the impact of the disease on patients’ quality of life. The hope is that these methods will prove capable of detecting changes in the patients’ disease. The team also hopes to shed new light on visual impairment in intermediate AMD and its progression, as well as the risk factors that cause the disease to progress faster in some patients than others.

By developing and validating new methods to study disease progression in dry AMD, the overall goal of MACUSTAR is to help drug development and make clinical trials of potential treatments more efficient.

Achievements & News

700 people with age-related macular degeneration recruited for MACUSTAR clinical study
April 2020

The MACUSTAR project has completed recruitment of over 700 people with age-related macular degeneration (AMD) for a clinical study. The objective of the study is to develop endpoints for the intermediate form of the disease (intermediate age-related macular degeneration, or iAMD).###

Late-stage AMD is one of the major blinding diseases for elderly people. Today, a large proportion of the elderly population across Europe is already affected by the disease, as studies involving large cohorts indicate. With current demographic trends, the number of affected is expected to increase considerably. As the disease progresses from iAMD to late AMD, many are at high risk of severe visual loss.

One barrier to the development of new treatments that could delay or stop the progression of the disease is the lack of tests that can determine the effectiveness of treatments being developed. The objective of MACUSTAR is to provide the much-needed tools that can analyse the efficacy of new treatments in clinical trials. The project intends to develop and validate functional, structural as well as patient-reported outcome measures for iAMD that are clinically meaningful and acceptable to regulatory agencies and payers. Risk factors for progression from iAMD to late AMD will also be investigated.

Read more

Changing light levels a challenge for people with eye disease AMD
July 2019

People with the eye disease age-related macular degeneration (AMD) struggle more with navigation under changing light levels than under constant low light conditions, according to initial results presented by the MACUSTAR project at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).### If the findings are confirmed in a larger group of patients, they will give us a better understanding of the impact of lighting on navigation and other everyday activities in people with AMD. People with dry age-related macular degeneration (AMD) gradually lose their central vision, usually in both eyes. It is a leading cause of blindness worldwide. However, as patients retain peripheral vision, the disease is not thought to affect mobility. In this study, people with AMD navigated their way around an obstacle-strewn maze at different light levels: 256 lux (equivalent to muted office lighting); 4 lux (equivalent to a road lit by streetlamps at night); and 1 lux (equivalent to moonlight). They also navigated the maze as the light level fell from 256 lux to 1 lux. While the participants’ performance was similar when navigating while the light level remained stable, it was a lot worse while navigating under changing light conditions. Their walking speed dropped by an average of 19 % compared to the 256 lux maze, and they experienced more mobility and orientation errors. The project is now gathering further data to confirm their findings and analyse if and how performance differs for patients at different stages of the disease. They will also verify if the findings at the two centres used (in Paris and London) are comparable. The research was led by Dr Hannah Dunbar of UCL and Ariel Zenouda of StreetLab, Paris – watch a short video where Dr Dunbar describes her work in MACUSTAR.

Participants Show participants on map

EFPIA companies
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Carl Zeiss Meditec AG, Jena, Germany
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Novartis Pharma AG, Basel, Switzerland
Universities, research organisations, public bodies, non-profit groups
  • Aibili Associacao Para Investigacao Biomedica E Innovacao Em Luz E Imagem, Coimbra, Portugal
  • City University Of London, London, United Kingdom
  • Ecrin European Clinical Research Infrastructure Network, Paris, France
  • Fondation De Cooperation Scientifique Voir Et Entendre, Paris, France
  • Moorfields Eye Hospital Nhs Foundation Trust, London, United Kingdom
  • Stichting Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
  • The University Of Sheffield, Sheffield, United Kingdom
  • Universitatsklinikum Bonn, Bonn, Germany
  • University College London, London, United Kingdom
Third parties
  • Assistance Publique Hopitaux De Paris, Paris, France
  • Centre Hospitalier National D'Ophtalmologie Des Quinze-Vingts, Paris, France
  • Kks-Netzwerk Ev -Netzwerk Der Koordinierungszentren Fur Klinische Studien, Berlin, Germany
  • Streetlab, Paris, France
  • Universidade Nova De Lisboa, Lisboa, Portugal
Project leader
Sergio Leal