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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.
ClinicalTrials.gov Identifier: NCT03712670
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
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

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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

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

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.

Publications:
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Responsible Party: Francesco Semeraro, Dr. Francesco Semeraro, Università degli Studi di Brescia
ClinicalTrials.gov Identifier: NCT03712670     History of Changes
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Retinal Diseases
Eye Diseases
Carotenoids
Pyranoprofen
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants