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

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)

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.

Study Overview

• Status: Unknown
• Conditions: AMD
• Intervention / Treatment: Dietary supplement: Visucomplex Plus

• Study Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy
    • Not yet recruiting
    • ASST Spedali Civili di Brescia
    • Contact: Francesco Semeraro
  • Roma, Italy
    • Recruiting
    • Ospedale Policlinico Casilino
    • Contact: Andrea Corsi
  • Napoli
    • Acerra, Napoli, Italy
      • Recruiting
      • Casa di cura Villa dei Fiori
      • Contact: Aldo Gelso
  • Pisa
    • Pontedera, Pisa, Italy
      • Recruiting
      • Ospedale Felice Lotti
      • Contact: Michele Palla

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with AMD (dry or wet)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Visucomplex Plus monotherapy; Patients with early dry AMD will be treated with Visucomplex Plus monotherapy.	Dietary supplement: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of QoL in patients affected by AMD (dry or wet) measured through a questionnaire self-administered by the patient partially derived from the VFQ-25, aiming to define a new assessment instrument coupled with the routinely clinical follow up.	QoL measured through a new questionnaire self-administered	measured at baseline and after 4-8 and 12 months of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of improvement scoring of QoL between VFQ-25 and a newly conceived questionnaire	Comparison of improvement scoring of Quality of Life between the two questionnaires (VFQ-25 and a newly conceived one) at baseline and after 4-8 and 12 months of treatment. VFQ-25 is a valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ).	measured at baseline and after 4-8 and 12 months of treatment.
Visual acuity	Evaluation of disease progression through Visual acuity.	measured at baseline and after 4-8 and 12 months of treatment.
OCT	Evaluation of disease progression through Optical Coherence Tomography (OCT).	measured at baseline and at the end of the observation period (12 months).
Questionnaire completion compliance	Evaluation of improvement of completion compliance of the new questionnaire versus standard of care one (VFQ-25). VFQ-25 is a valid 25-item version of the 51-item National Eye Institute Visual Function Questionnaire (NEI-VFQ).	measured at the end of the observation period (12 months).
Likert scales (5 points)	Evaluation of Patient's treatment judgement and improvement of condition (Likert Scales). A Likert scale is a rating scale where patients have to indicate their treatment judgement and improvement of condition crossing a score from 1 to 5.	measured at baseline and after 4-8 and 12 months of treatment.
subject and investigator satisfaction: questionnaire	Evaluation of subject and investigator satisfaction of the new questionnaire. Subject and investigator satisfaction is to be indicated on a scale crossing a score from 1 to 5.	measured at baseline and after 4-8 and 12 months of treatment.

Collaborators and Investigators

• Sponsor: VISUfarma SpA

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2019
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 27, 2020
• Last Update Submitted That Met QC Criteria: April 24, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: VF-AMD-VSCLX-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No