Real World Study to Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With Dry and Wet Age-related Macular Degeneration (AMD)
| Registry | NCT04177069 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 160 (Estimated) |
| Sponsor | VISUfarma SpA (Industry) |
| Conditions | AMD |
| Interventions | Visucomplex Plus (Dietary supplement) |
| Dates | start 2019-12-11, primary completion 2020-12-30 (estimated), completion 2020-12-30 (estimated), first posted 2019-11-26, last updated 2020-04-27 |
| Locations | 4 sites in Italy |
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All trials for AMD All trials of Visucomplex Plus
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Visucomplex Plus monotherapy | Dietary Supplement: Visucomplex Plus | Patients with early dry AMD will be treated with Visucomplex Plus monotherapy. | |
| anti-VEGF drug plus Visucomplex Plus | Dietary Supplement: Visucomplex Plus | Dry or wet AMD patients under treatment with a stable dose of an anti-VEGF drug, Visucomplex Plus will be added-on, upon physician decision. |
Sex: All
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Casa di Cura Villa dei Fiori | Acerra, Napoli | Italy | Recruiting |
| Ospedale Felice Lotti | Pontedera, Pisa | Italy | Recruiting |
| ASST Spedali Civili di Brescia | Brescia | Italy | Not yet recruiting |
| Ospedale Policlinico Casilino | Roma | Italy | Recruiting |