Research & Innovation - Participant Portal

TOPIC : DRY AGE-RELATED MACULAR DEGENERATION: DEVELOPMENT OF NOVEL CLINICAL ENDPOINTS FOR CLINICAL TRIALS WITH A REGULATORY AND PATIENT ACCESS INTENTION

Topic identifier: IMI2-2015-07-04
Publication date: 18 December 2015

Types of action: IMI2-RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
18 December 2015
Deadline:
2nd stage Deadline:
17 March 2016 17:00:00
06 September 2016 17:00:00

Time Zone : (Brussels time)
  Horizon 2020
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.

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.

You can access the description of the different topics in the Call topics text.

The budget breakdown for this Call is given at the end of the Call topics text, in the Call Conditions section (page 78), as well as the following information : 
 

  1. List of countries and applicable rules for funding
     
  2. Eligibility and admissibility conditions
     
  3. Evaluation criteria and procedure, scoring and threshold : described in the IMI Manual for Submission, Evaluation and Grant award
     
  4. Indicative timetable for evaluation and grant agreement
     
  5. Provisions, proposal templates and evaluation forms for the type(s) of action(s) under this topic:

    IMI2 Research and Innovation Action (IMI2-RIA) and (IMI2-IA):

    Summary of the most relevant provisions for participating in IMI2 actions
    Standard proposal template
    Standard evaluation form
    IMI2 Model Grant Agreement
    Template for Essential Clinical Trials Information

    MI2 Coordination and Support Action (IMI2-CSA):

    Summary of the most relevant provisions for participating in IMI2 actions
    Standard proposal template
    Standard evaluation form
    IMI2 Model Grant Agreement
    Template for Essential Clinical Trials Information
     

 

Submission Service

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