NCT04177069

Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With AMD

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: VISUfarma SpA · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

• AMD

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Visucomplex Plus	capsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper.

Timeline

• Start date: 2019-12-11
• Primary completion: 2020-12-30
• Completion: 2020-12-30
• First posted: 2019-11-26
• Last updated: 2020-04-27

Locations

4 sites across 1 country: Italy