Diabetic Macular Edema, Macular Degeneration, Age Related, Macular Edema of Right Retina (Diagnosis), Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy
Conditions
Brief 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.
Detailed description
Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.
Interventions
DEVICEVISUPRIME
twice daily
DEVICEPlacebo
twice daily
Sponsors
CROlife
VISUfarma SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study and therefore participants and clinical staff are not aware of the treatment group assigned to each participant.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (age ≥ 18) * Naïve and pre-treated patients scheduled for IVI * Diagnosis of one of the following: * ARMD * mCNV * Proliferative diabetic retinopathy * 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).
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CFU (Colony Forming Units) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic sensitivity | three days | Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique. |
| SANDE Symptom Assessment iN Dry Eye | three days | 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. |
| Adverse Events | three days | Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment. |
Countries
Italy
Outcome results
None listed