Nutraceutical Support With Omega-3

Not Applicable

Completed

• Conditions: Retinal Disease
• Interventions: Drug: Aflibercept; Dietary Supplement: Carotenoids; Drug: Pranoprofen

• Registration Number: NCT03712670
• Lead Sponsor: Università degli Studi di Brescia

Brief Summary

Although evidence have clearly proved that intravitreal injection of vascular endothelial growth factor antagonists prevents vision loss and may even improve visual acuity in patients with neovascular AMD, a significant percentage of patients continue to lose visual acuity. Moreover, monthly intravitreal injections represent a burden for society as well as the caregiver.

Combination therapy with either topical 0.1% pranoprofen or nutraceutical support with AREDS2 formula plus omega-3 might act synergistically with intravitreal injection, offering valuable therapeutic support to aflibercept injections in patients requiring long-term treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-03-15
• Status Verified: 2018-10
• Study First Submitted: 2018-10-17
• Study First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Study First Posted: 2018-10-19
• Last Update Posted: 2018-10-19

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
AP group	Aflibercept	Intravitreal aflibercept along with 0.1% pranoprofen
AN group	Carotenoids	Intravitreal aflibercept plus daily supplementation of nutraceutical tablets
AM group	Aflibercept	Intravitreal aflibercept monotherapy
AP group	Pranoprofen	Intravitreal aflibercept along with 0.1% pranoprofen
AN group	Aflibercept	Intravitreal aflibercept plus daily supplementation of nutraceutical tablets

Primary Outcome Measures

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