VISUPRIME® Eye Drops
Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation, Proliferative Diabetic Retinopathy
About this trial
This is an interventional prevention trial for Macular Degeneration, Age Related
Eligibility Criteria
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.
Sites / Locations
- Ospedale Santa Maria della Misericordia
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Investigational Device
Placebo