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

Phase 4

Completed

• Conditions: Macular Edema
• Interventions: Drug: Aflibercept Injection [Eylea]; Drug: Omega-3 Supplementation; Drug: Pranoprofen Eyedrops

• Registration Number: NCT03355638
• Lead Sponsor: Università degli Studi di Brescia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-07
• Study Completion: 2017-07
• Status Verified: 2017-11
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-11-22
• Last Update Submitted: 2017-11-22
• Study First Posted: 2017-11-28
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• provision of written informed consent and compliance with study assessments for the full duration of the study
• age > 40 years
• presence of treatment-naïve neovascular AMD.

Exclusion Criteria

• any previous intravitreal treatment
• previous laser treatment in the study eye
• myopia > 7 diopters in the study eye
• concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and advanced glaucoma)
• concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal
• known sensitivity to any component of the formulations being investigated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aflibercept plus nutraceutical	Omega-3 Supplementation	All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients were given daily tablets of Omega-3 supplementation (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).
aflibercept monotherapy	Aflibercept Injection [Eylea]	All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata
aflibercept plus pranoprofen	Pranoprofen Eyedrops	All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of pranoprofen (Pranoflog; Sifi SpA, Aci Sant'Antonio, CT, Italy) three times a day for 12 months. All patients were followed up for 12 months.
aflibercept plus nutraceutical	Aflibercept Injection [Eylea]	All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients were given daily tablets of Omega-3 supplementation (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).
aflibercept plus pranoprofen	Aflibercept Injection [Eylea]	All patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of pranoprofen (Pranoflog; Sifi SpA, Aci Sant'Antonio, CT, Italy) three times a day for 12 months. All patients were followed up for 12 months.

Primary Outcome Measures

Name	Time	Method
Central Retinal Thickness (microns)	12-month	Optical Coherence Tomography will be used to assess central retinal thickness.
Visual Acuity (LogMAR)	12-month	ETDRS charts will be used to assess best corrected visual acuity