Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT02395757
Eligibility Criteria:
Inclusion Criteria:
* Patient aged 50 years or over;
* Patient who has given their free, informed, signed consent;
* Patient with a French social security number or equivalent cover;
* Patient presenting one eye with stage 4 AMD (according to the AREDS classification), and drusen in the fellow eye (study eye) with at least one drusen with a diameter of over 125 microns and/or extra- foveal atrophy (stage 3 AREDS);
* Patient who is willing and able to attend all the clinical appointments required for the study and complete all the related procedures.
Exclusion Criteria:
* Patient aged under 50 years;
* Patient who refuses to take part in the study;
* Woman who is pregnant or breastfeeding;
* Protected adult as set out in French law (French Public Health Law);
* Patient presenting a study eye with stage 1, 2 or 4 AMD (AREDS classification);
* Patient presenting another maculopathy in the study eye;
* Area alteration (cornea, lens, vitreous humour) which makes it impossible to carry out and interpret the microperimetry correctly;
* Patient due to undergo cataract surgery in the study eye during the 2-year study period;
* Patients who cannot be followed up for the full 2 years;
* Patients participating simultaneously in other studies which may interfere with the study results (in either eye).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT02395757
Study Brief:
Protocol Section:
NCT02395757