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

AMD Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04177069
• Other study ID #: VF-AMD-VSCLX-2019
• Status: Recruiting
• Start date: December 11, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2020
• Source: VISUfarma SpA
• Contact: Anna Rita Bigioni
• Phone: +39 06 3630 6842
• Email: a.bigioni[@]visufarma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• AMD

Intervention

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.

Locations

Country	Name	City	State
Italy	Casa di Cura Villa dei Fiori	Acerra	Napoli
Italy	ASST Spedali Civili di Brescia	Brescia
Italy	Ospedale Felice Lotti	Pontedera	Pisa
Italy	Ospedale Policlinico Casilino	Roma

Sponsors (1)

Lead Sponsor	Collaborator
VISUfarma SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Visual acuity	Evaluation of disease progression through Visual acuity.	measured at baseline and after 4-8 and 12 months of treatment.
Secondary	OCT	Evaluation of disease progression through Optical Coherence Tomography (OCT).	measured at baseline and at the end of the observation period (12 months).
Secondary	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).
Secondary	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.
Secondary	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.