Nutraceutical Support With Omega-3

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.

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Key information

Conditions

Retinal Disease Eye Diseases Retinal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

aflibercept

Drug

monthly intravitreal injections

Pranoprofen

Drug

0.1% pranoprofen 3 times a day topical eye drops administration

Carotenoids

Dietary Supplement

daily supplementation of nutraceutical tablets containing the AREDS2 formulation

Primary outcomes

Central Retinal Thickness (microns)

Time frame: 12-month

Optical Coherence Tomography will be used to assess central retinal thickness.
Visual Acuity (LogMAR)

Time frame: 12-month

ETDRS charts will be used to assess best corrected visual acuity

Sponsors and collaborators

Lead sponsor

Università degli Studi di Brescia

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: Oct 19, 2018
Registry last updated: Oct 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed