Macular Degeneration, Age RelatedNCT05677685
VISUPRIME® Eye Drops
A study testing VISUPRIME in people with Macular Degeneration, Age Related and Myopic Choroidal Neovascularisation, run by VISUfarma SpA at 6 sites in Italy.
Trial summary
The study purpose is to assess the efficacy of VISUPRIME® eye drops in preventing the conjunctival bacterial load in patients undergoing to anti-VEGF injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy
- What is being tested?
- VISUPRIME
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 6 sitesItaly
- Study dates
- 22 Jun 2023to 23 Jan 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18)
- Naïve and pre-treated patients scheduled for IVI
- Diagnosis of one of the following:
- ARMD
- mCNV
- Proliferative diabetic retinopathy
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- Diabetic macular oedema
- Macular oedema secondary to retinal vein occlusion
- The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the local Ethics Committee (EC).
Who cannot join
- Use of systemic antibiotics, corticosteroids within 3 months
- Use of topical antibiotics and or corticosteroids within 15 days from study enrolment
- Use of topical Artificial Tears within 15 days from the enrolment
- Use of topical antiseptic agents within 1 month from study enrolments
- Presence of topical ocular therapies that cannot be suspended for the entire duration of the study
- Ongoing ocular or systemic inflammatory or infectious processes
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- Known hypersensitivity to the constituents of the study product
- Diagnosis of Open-Angle Glaucoma
- Uveitis
- Acute and Chronic Conjunctival Disease
- Any intraocular surgery within 6 months from study enrolment, excluded IVI
- Severe and Moderate Dry Eye
- Pregnancy or breast-feeding
- Participation in other clinical studies
- Patients with cognitive impairment and unable to manage home-assigned treatment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, BA, 70124
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100
Ospedale Santa Maria della Misericordia
Perugia, PG, 06156
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, 00168
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, TS, 34148
About this study
Official title: Multicentre Randomized Double-blind Trial of VISUPRIME® Eye Drops to be Evaluated in Preventing the Conjunctival Bacterial Load in Patients Undergoing to Anti-VEGF Injection
The study purpose is to assess the efficacy of VISUPRIME® eye drops in preventing the conjunctival bacterial load in patients undergoing to anti-VEGF injection.
Read the detailed description
Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.
- Conditions
- Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema of Right Retina (Diagnosis)
- Being tested
- VISUPRIME, Placebo
- Medical subject headings
- Macular Degeneration, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISUPRIMEDevice
twice daily
PlaceboDevice
twice daily
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Active comparator | Not described Receives: Device: VISUPRIME |
| Placebo | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CFU (Colony Forming Units)
Primary endpoint is to evaluate the change in bacterial loads in terms of CFU/ sample in the two groups at V0 compared to V1.
Measured: three days
Secondary outcomes (3)
Antibiotic sensitivity
Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.
Measured: three days
SANDE Symptom Assessment iN Dry Eye
The assessment of ocular irritation symptoms at V0 and V1, using a 2-item Symptom Assessment iN Dry Eye (SANDE) questionnaire consistent with all ocular diseases that may impact vision-related functioning.
Measured: three days
Adverse Events
Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start22 Jun 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, Age RelatedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients who meet the study inclusion criteria will be randomized in a 1:1 assignment ratio to the study group or control group in a double-blind manner.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- VISUfarma SpA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CROlife
- Responsible party
- Sponsor
- Investigators
- Anna Rita Bigioni, PhD, Study chair, CROlife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677685
- Sponsor's protocol ID
- VF-03-2022
- Status last verified
- Jul 2024
- First submitted
- 12 Dec 2022
- Last updated
- 19 Jul 2024
- 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 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Randomized Double-blind Trial of VISUPRIME® Eye Drops to be Evaluated in Preventing the Conjunctival Bacterial Load in Patients Undergoing to Anti-VEGF Injection
- ClinicalTrials.gov ID
- NCT05677685
- Acronym / sponsor ID
- VF-03-2022
- Conditions
- Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy, Diabetic Macular Edema, Macular Edema of Right Retina (Diagnosis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- VISUfarma SpAIndustry (pharma, biotech, devices)
- Collaborators
- CROlife
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 10 Jan 2023 (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.
The study purpose is to assess the efficacy of VISUPRIME® eye drops in preventing the conjunctival bacterial load in patients undergoing to anti-VEGF injection.
Detailed description
Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients who meet the study inclusion criteria will be randomized in a 1:1 assignment ratio to the study group or control group in a double-blind manner.
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Active comparator | Device: VISUPRIME |
| Placebo | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients (age ≥ 18)
- Naïve and pre-treated patients scheduled for IVI
- Diagnosis of one of the following:
- The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the local Ethics Committee (EC).
Key exclusion criteria (15 listed)
- Use of systemic antibiotics, corticosteroids within 3 months
- Use of topical antibiotics and or corticosteroids within 15 days from study enrolment
- Use of topical Artificial Tears within 15 days from the enrolment
- Use of topical antiseptic agents within 1 month from study enrolments
- Presence of topical ocular therapies that cannot be suspended for the entire duration of the study
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 |
|---|---|---|
| VISUPRIMEtwice daily | Device | Investigational Device |
| Placebotwice daily | Device | Placebo |
Primary outcome
CFU (Colony Forming Units)
Time frame: three days
Primary endpoint is to evaluate the change in bacterial loads in terms of CFU/ sample in the two groups at V0 compared to V1.
3 secondary outcomes
Antibiotic sensitivity
Time frame: three days
SANDE Symptom Assessment iN Dry Eye
Time frame: three days
Adverse Events
Time frame: three days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- 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.
Anna Rita Bigioni, PhD study chair
CROlife
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISUPRIME in people with Macular Degeneration, Age Related and Myopic Choroidal Neovascularisation, run by VISUfarma SpA at 6 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 9 inclusion and 15 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: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CFU (Colony Forming Units) (time frame: three days). 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 19 Jul 2024.