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

• Conditions: AMD
• Interventions: Dietary Supplement: Visucomplex Plus

• Registration Number: NCT04177069
• Lead Sponsor: VISUfarma SpA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-12
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Study Start: 2019-12-11
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-24
• Last Update Posted: 2020-04-27
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
anti-VEGF drug plus Visucomplex 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 monotherapy	Visucomplex Plus	Patients with early dry AMD will be treated with Visucomplex Plus monotherapy.

Primary Outcome Measures

Name	Time	Method
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.	measured at baseline and after 4-8 and 12 months of treatment.	QoL measured through a new questionnaire self-administered

Secondary Outcome Measures

Name	Time	Method
Visual acuity	measured at baseline and after 4-8 and 12 months of treatment.	Evaluation of disease progression through Visual acuity.
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.	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).
OCT	measured at baseline and at the end of the observation period (12 months).	Evaluation of disease progression through Optical Coherence Tomography (OCT).
Questionnaire completion compliance	measured at the end of the observation period (12 months).	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).
Likert scales (5 points)	measured at baseline and after 4-8 and 12 months of treatment.	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.
subject and investigator satisfaction: questionnaire	measured at baseline and after 4-8 and 12 months of treatment.	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.

Trial Locations

Locations (4)

Ospedale Felice Lotti; 🇮🇹 Pontedera, Pisa, Italy

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Casa di Cura Villa dei Fiori; 🇮🇹 Acerra, Napoli, Italy

Ospedale Policlinico Casilino; 🇮🇹 Roma, Italy