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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03712670

Enrollment

Registered

2018-10-19

Start date

2016-01-01

Completion date

2017-03-15

Last updated

2018-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Disease

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.

Interventions

DRUGAflibercept

monthly intravitreal injections

DRUGPranoprofen

0.1% pranoprofen 3 times a day topical eye drops administration

DIETARY_SUPPLEMENTCarotenoids

daily supplementation of nutraceutical tablets containing the AREDS2 formulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026