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DRY AGE-RELATED MACULAR DEGENERATION: DEVELOPMENT OF NOVEL CLINICAL ENDPOINTS FOR CLINICAL TRIALS WITH A REGULATORY AND PATIENT ACCESS INTENTION
Deadline: 06 Sep 2016   CALL EXPIRED

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 Health Care
 Pharmaceuticals
 E-Health
 Medical Biotechnology
 Horizon2020

Topic Description
Specific Challenge:

Age-related macular degeneration (AMD) is a chronic disease and among the leading causes of blindness world-wide. Currently no effective treatments exist to address the major health problems of transition of intermediate AMD to late stage AMD with ‘geographic’ atrophy (GA). The development of novel pharmaceutical compounds is mainly limited by the lack of validated functional and structural clinical endpoints that can be used.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.

Scope:

To develop clinical endpoints that are meaningful to patients and need to measure visual dysfunction beyond best-corrected visual acuity (BCVA), which is currently the only generally accepted functional clinical endpoint in retinal diseases.

Candidate clinical endpoints need to be systematically validated in adequate patient populations to be acceptable for regulatory authorities, health technology assessment (HTA) bodies, and payers.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.

Expected Impact:

An extended toolbox of validated clinical endpoints that are acceptable by regulators, HTA bodies/payers and patients will enable the development of therapeutics for dry AMD.

It will greatly facilitate future trial designs in dry AMD, in early clinical trials, which aim to show proof of new therapeutic concepts in patients, as well in late stage development targeting confirmation of efficacy and safety of novel therapeutic approaches in larger patient populations.

Please refer to the full topic text on the IMI2 Call 7 section of the IMI website.



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