COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Nutraceutical Support With Omega-3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03712670
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Information provided by (Responsible Party):
Francesco Semeraro, 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.

Condition or disease Intervention/treatment Phase
Retinal Disease Drug: Aflibercept Drug: Pranoprofen Dietary Supplement: Carotenoids Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Exudative Age-Related Macular Degeneration With Aflibercept Combined With Pranoprofen Eye Drops or Nutraceutical Support With Omega-3: A Randomized Trial
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aflibercept

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

Primary Outcome Measures :
  1. Central Retinal Thickness (microns) [ Time Frame: 12-month ]
    Optical Coherence Tomography will be used to assess central retinal thickness.

  2. Visual Acuity (LogMAR) [ Time Frame: 12-month ]
    ETDRS charts will be used to assess best corrected visual acuity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Layout table for additonal information
Responsible Party: Francesco Semeraro, Dr. Francesco Semeraro, Università degli Studi di Brescia Identifier: NCT03712670    
Other Study ID Numbers: Oral001
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Eye Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants