An interventional study of VISUPRIME and Placebo in Macular Degeneration, Age Related, Myopic Choroidal Neovascularisation and Proliferative Diabetic Retinopathy, sponsored by VISUfarma SpA. Completed at 6 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-19.
Sponsored by VISUfarma SpA · Not applicable, Interventional, and Prevention
Among 97 studies in Macular Degeneration with a site in Italy — 22 open to participants now, 31 under way, 10 of them phase 3. Macular Degeneration · Italy.
Among the 97 studies in Macular Degeneration with a site in Italy, this one is the 53rd largest by enrollment of the 76 interventional ones, is one of 6 that started in 2023, is one of 20 with no phase, and was the 67th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
This study's enrollment of 78 is above the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →22 of the 97 studies in Macular Degeneration with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 165 Macular Degeneration studies recruiting now, 116 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →97 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 6 started in 2023.
Median enrollment 272 across the 76 interventional studies, 160 across the 20 observational. Of the 60 that completed or were terminated, 36 (60%) have results posted.
68 of 97 have an industry lead sponsor. The 10 most frequent:
VISUfarma SpA is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
VISUfarma SpA has 1 study filed under Macular Degeneration — fewer than ten, so there is no comparison to draw.
9 of the studies in Macular Degeneration with a site in Italy that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04657289Phase 3Hoffmann-La RocheA Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome) | 2027-02-04 |
| NCT06373731Phase 3Stealth BioTherapeutics Inc.ReNEW:Phase 3 Study of Efficacy, Safety & Pharmacokinetics of Subcutaneous Injections of Elamipretide in Subjects With Dry Age-Related Macular Degeneration (Dry AMD) | 2027-08 |
| NCT07064759Phase 34D Molecular TherapeuticsSingle Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration | 2027-11 |
| NCT06906003Fondazione G.B. Bietti, IRCCSVisual Rehabilitation and Depression in Visually Impaired Patients With AMD | 2026-12-02 |
| NCT07338461Heidelberg Engineering GmbHHigh Resolution Imaging OCT Study | 2026-12-30 |
Among the 97 studies in Macular Degeneration with a site in Italy, from their registry updates:
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.
Multicentre, double-masked, placebo-controlled randomized 1:1 of the VISUPRIME® treatment in patients undergoing intravitreal anti-VEGF injection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: VISUPRIME
Device: Placebo
twice daily
twice daily
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.
Time frame: three days
Antibiotic sensitivity
Identification of microorganism sensitivity or resistant to various antibiotics using antibiogram technique.
Time frame: 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.
Time frame: three days
Adverse Events
Evaluation of the rate of related Adverse Events (AEs) that occur during the study treatment.
Time frame: three days
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2023 to primary completion in Jan 2024, 7 months.
Of 132 interventional studies with no phase under Macular Degeneration, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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VISUfarma SpA