Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With AMD
NCT ID: NCT04177069
Last Updated: 2020-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2019-12-11
2020-12-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Visucomplex Plus monotherapy
Patients with early dry AMD will be treated with Visucomplex Plus monotherapy.
Visucomplex Plus
capsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper.
anti-VEGF drug plus 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.
Visucomplex Plus
capsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper.
Interventions
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Visucomplex Plus
capsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
ALL
No
Sponsors
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VISUfarma SpA
INDUSTRY
Responsible Party
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Locations
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Casa di Cura Villa dei Fiori
Acerra, Napoli, Italy
Ospedale Felice Lotti
Pontedera, Pisa, Italy
ASST Spedali Civili di Brescia
Brescia, , Italy
Ospedale Policlinico Casilino
Roma, , Italy
Countries
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Central Contacts
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Facility Contacts
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Aldo Gelso
Role: primary
Michele Palla
Role: primary
Francesco Semeraro
Role: primary
Andrea Corsi
Role: primary
Other Identifiers
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VF-AMD-VSCLX-2019
Identifier Type: -
Identifier Source: org_study_id
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