NCT03355638

Treatment of CNV With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3

Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Università degli Studi di Brescia · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

To determine whether a combination of intravitreal aflibercept and pranoprofen eyedrops or nutraceutical support provides additional benefit over IVA monotherapy for the treatment of choroidal neovascularization in age-related macular degeneration.

Conditions

• Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept Injection [Eylea]	patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata
DRUG	Pranoprofen Eyedrops	Patients were given a bottle of eyedrops for self-administration of 0.1% pranoprofen (Pranoflog, Sifi SpA, Aci Sant'Antonio, CT, Italy). Pranoprofen dosage was 1 drop in the study eye, 3 times a day, over the 12-month study period
DRUG	Omega-3 Supplementation	Ppatients were given daily tablets of Omega-3 supplementation provided free of charge by the company (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-07-01
• Completion: 2017-07-01
• First posted: 2017-11-28
• Last updated: 2017-11-28