AMDNCT04177069
Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With AMD
An observational study of AMD, run by VISUfarma SpA at 4 sites in Italy.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- AMD
- What is being tested?
- Visucomplex Plus
- Type of treatment
- Pill or oral medicine
- How many people
- 160 participants
- Where
- 4 sitesItaly
- Study dates
- 11 Dec 2019to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with AMD (dry or wet)
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 4 recruiting
- Recruiting
Casa di Cura Villa dei Fiori
Acerra, Napoli
Aldo Gelso
- Not yet recruiting
ASST Spedali Civili di Brescia
Brescia
Francesco Semeraro
- Recruiting
Ospedale Felice Lotti
Pontedera, Pisa
Michele Palla
- Recruiting
Ospedale Policlinico Casilino
Roma
Andrea Corsi
About this study
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)
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.
Read more
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
- Being tested
- Visucomplex Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visucomplex PlusDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Visucomplex Plus monotherapy | Patients with early dry AMD will be treated with Visucomplex Plus monotherapy. Receives: 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. Receives: Dietary Supplement: Visucomplex Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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
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: measured at baseline and after 4-8 and 12 months of treatment.
Visual acuity
Evaluation of disease progression through Visual acuity.
Measured: measured at baseline and after 4-8 and 12 months of treatment.
OCT
Evaluation of disease progression through Optical Coherence Tomography (OCT).
Measured: 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: 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: 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: measured at baseline and after 4-8 and 12 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start11 Dec 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177069
- Sponsor's protocol ID
- VF-AMD-VSCLX-2019
- Status last verified
- Apr 2020
- First submitted
- 12 Jul 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04177069
- Acronym / sponsor ID
- VF-AMD-VSCLX-2019
- Conditions
- AMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visucomplex Plus monotherapy | – | Dietary Supplement: Visucomplex PlusPatients with early dry AMD will be treated with Visucomplex Plus monotherapy. |
| anti-VEGF drug plus Visucomplex Plus | – | Dietary Supplement: Visucomplex PlusDry or wet AMD patients under treatment with a stable dose of an anti-VEGF drug, Visucomplex Plus will be added-on, upon physician decision. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with AMD (dry or wet)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visucomplex Pluscapsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper. | Dietary supplement | Visucomplex Plus monotherapy, anti-VEGF drug plus Visucomplex Plus |
Primary outcome
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.
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
QoL measured through a new questionnaire self-administered
6 secondary outcomes
Comparison of improvement scoring of QoL between VFQ-25 and a newly conceived questionnaire
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
Visual acuity
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
OCT
Time frame: measured at baseline and at the end of the observation period (12 months).
Questionnaire completion compliance
Time frame: measured at the end of the observation period (12 months).
Likert scales (5 points)
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
subject and investigator satisfaction: questionnaire
Time frame: measured at baseline and after 4-8 and 12 months of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AMD, run by VISUfarma SpA at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bigioni (+39 06 3630 6842, a.bigioni@visufarma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: measured at baseline and after 4-8 and 12 months of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.