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 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
NCT ID:
NCT02569892
Eligibility Criteria:
Inclusion Criteria
1. Older than 60 years of age.
2. Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
3. Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
4. Able to give an informed consent.
Exclusion Criteria:
1. Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
2. Previous macular laser treatment.
3. Any previous ocular condition that may be associated with a risk of developing macular oedema.
4. Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
5. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
6. Important known allergies to sodium fluorescein dye used in angiography.
7. Ocular or periocular infections.
8. Planned intra-ocular surgery within one year.
9. Patient is unavailable for follow-up visits.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02569892
Study Brief:
Protocol Section:
NCT02569892