Nutraceutical Support With Omega-3

October 17, 2018 updated by: Francesco Semeraro, Università degli Studi di Brescia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AM group
Intravitreal aflibercept monotherapy
Drug: Aflibercept
monthly intravitreal injections
Experimental: AP group
Intravitreal aflibercept along with 0.1% pranoprofen
Drug: Aflibercept
monthly intravitreal injections
Drug: Pranoprofen
0.1% pranoprofen 3 times a day topical eye drops administration
Experimental: AN group
Intravitreal aflibercept plus daily supplementation of nutraceutical tablets
Drug: Aflibercept
monthly intravitreal injections
Dietary supplement: Carotenoids
daily supplementation of nutraceutical tablets containing the AREDS2 formulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Brescia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

March 15, 2017

Study Registration Dates

First Submitted

October 17, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 17, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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