Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With AMD

VISUfarma

Status

Unknown

Conditions

AMD

Treatments

Dietary Supplement: Visucomplex Plus

Study type

Observational

Funder types

Industry

Identifiers

NCT04177069

VF-AMD-VSCLX-2019

Details and patient eligibility

About

This is an observational study in which patients affected by dry or wet AMD will be enrolled, after signing the Informed Consent, according to eligibility criteria.

Patients, after signing the Informed Consent, will enter into a screening phase during which the concomitant medication, clinical history, physical examination (including smoking habits) will be checked and the inclusion/exclusion criteria will be assessed.

Then, at the time of Baseline visit (V0) the eligible patients will be given Visucomplex Plus as monotherapy, 1 capsule daily after food, or for dry or wet AMD patients under treatment with a stable dose of an anti-VEGF drug, Visucomplex Plus, 1 capsule daily after food, upon physical decision.

Screening phase and the baseline visit (V0) could coincide.

Enrollment

160 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient Informed consent form (ICF) signed
Adult male and female irrespective of their age at the time of the signature of ICF
Patients affected by dry or wet AMD irrespective of the disease severity and including newly diagnosed patients
Patients with no treatment for AMD or under treatment with stable doses of anti-VEGF
Willing to follow all study procedures, including attending all site visits, tests and examinations.

Exclusion criteria

Previously diagnosed optic neuropathies
Decompensated diabetes or hypertension
Retinal pathologies including hereditary forms
Neurological, Neurodegenerative or Cerebrovascular conditions
Patients with a significantly progressive opacity of lens in the previous 3 months prior to enrolment
Surgical intervention for cataract in the previous 3 months prior to enrolment
Previously diagnosed eye inflammatory conditions (uveitis) in the previous 3 months
Refractive defects beyond the 5 spherical diopters, both positive and negative and over 3 cylindrical
Any clinically significant history of serious digestive tract, liver, kidney, cardiovascular or hematological disease,
Known drug and/or alcohol abuse
Mental incapacity that precludes adequate understanding or cooperation
Participation in another clinical study.