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

NCT04177069 | Unknown

• 1 other identifier: VF-AMD-VSCLX-2019
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Comparison of improvement scoring of QoL between VFQ-25 and a newly conceived questionnaire

  measured at baseline and after 4-8 and 12 months of treatment.

• Visual acuity

  measured at baseline and after 4-8 and 12 months of treatment.

• OCT

  measured at baseline and at the end of the observation period (12 months).

• Questionnaire completion compliance

  measured at the end of the observation period (12 months).

• Likert scales (5 points)

  measured at baseline and after 4-8 and 12 months of treatment.

Study Arms (2)

Visucomplex Plus monotherapy

Patients with early dry AMD will be treated with Visucomplex Plus monotherapy.

Dietary Supplement: Visucomplex Plus

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

Interventions

Visucomplex Plus DIETARY_SUPPLEMENT

capsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper.

Visucomplex Plus monotherapy; anti-VEGF drug plus Visucomplex Plus

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with AMD (dry or wet)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VISUfarma SpA: lead

Study Sites (4)

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

Central Study Contacts

Anna Rita Bigioni

CONTACT

+39 06 3630 6842; a.bigioni@visufarma.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: November 26, 2019
• Study Start: December 11, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 27, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)