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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT06557369
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients ≥ 50 years of age
* Intermediate AMD, Grade AREDS 3
* Both eyes eligible for the study Patients willing to enrol in a clinical study must sign a written informed consent form, cooperate with protocols, and comply with follow-up.
* Dietary supplements and life-style habits must remain unchanged, as far as possible, for the duration of investigation participation.
Exclusion Criteria:
* Myopia \> 8D
* Maximum pupillary aperture ᴓ4mm with medical dilation
* Anticipation of ocular surgery during the study
* Clinically significative cataract
* Ocular surgery 6 months or less before study entry
* No previous retinal treatment, neither anti-VEGF (Anti-Vascular Endothelial Growth Factor ) therapy nor laser photocoagulation
* Diabetic retinopathy
* Any other maculopathy and conditions as e.g. retinitis pigmentosa, DME (diabetic macular oedema), retinal lesions, retinal vessel occlusions etc
* Another obfuscating ocular disease including amblyopia, uncontrolled IOP (intraocular pressure), uncontrolled glaucoma or glaucomatous visual field loss, media opacity such as visually significant cataract, epiretinal membrane, vitreomacular traction, etc
* Concomitant systemic diseases and factors affecting the study, as per investigator's discretion
* Pregnant and lactating woman
* Concomitant participation in another interventional clinical study
* When it is expected that the patient will not be able to complete the trial due to mental health, age, or other personal issues.
* Photosensitivity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06557369
Study Brief:
Protocol Section:
NCT06557369