Clinical trial NCT04177069: Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With AMD
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AMD
Lead sponsor: VISUfarma SpA
Sponsor class: INDUSTRY
First posted: 2019-11-26
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with AMD (dry or wet)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: measured at baseline and after 4-8 and 12 months of treatment.
Secondary outcomes:
measure: Comparison of improvement scoring of QoL between VFQ-25 and a newly conceived questionnaire
timeFrame: measured at baseline and after 4-8 and 12 months of treatment.
measure: Visual acuity
timeFrame: measured at baseline and after 4-8 and 12 months of treatment.
measure: OCT
timeFrame: measured at baseline and at the end of the observation period (12 months).
measure: Questionnaire completion compliance
timeFrame: measured at the end of the observation period (12 months).
measure: Likert scales (5 points)
timeFrame: measured at baseline and after 4-8 and 12 months of treatment.
measure: subject and investigator satisfaction: questionnaire
timeFrame: measured at baseline and after 4-8 and 12 months of treatment.
Other outcomes:
Locations:
city: Acerra
country: Italy
facility: Casa di Cura Villa dei Fiori
state: Napoli
city: Pontedera
country: Italy
facility: Ospedale Felice Lotti
state: Pisa
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Roma
country: Italy
facility: Ospedale Policlinico Casilino
Study officials:
References: