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Nutraceutical Support With Omega-3

Primary Purpose

Retinal Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aflibercept
Pranoprofen
Carotenoids
Sponsored by
Università degli Studi di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    AM group

    AP group

    AN group

    Arm Description

    Intravitreal aflibercept monotherapy

    Intravitreal aflibercept along with 0.1% pranoprofen

    Intravitreal aflibercept plus daily supplementation of nutraceutical tablets

    Outcomes

    Primary Outcome Measures

    Central Retinal Thickness (microns)
    Optical Coherence Tomography will be used to assess central retinal thickness.
    Visual Acuity (LogMAR)
    ETDRS charts will be used to assess best corrected visual acuity

    Secondary Outcome Measures

    Full Information

    First Posted
    October 17, 2018
    Last Updated
    October 17, 2018
    Sponsor
    Università degli Studi di Brescia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03712670
    Brief Title
    Nutraceutical Support With Omega-3
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    March 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Università degli Studi di Brescia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Retinal Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AM group
    Arm Type
    Active Comparator
    Arm Description
    Intravitreal aflibercept monotherapy
    Arm Title
    AP group
    Arm Type
    Experimental
    Arm Description
    Intravitreal aflibercept along with 0.1% pranoprofen
    Arm Title
    AN group
    Arm Type
    Experimental
    Arm Description
    Intravitreal aflibercept plus daily supplementation of nutraceutical tablets
    Intervention Type
    Drug
    Intervention Name(s)
    Aflibercept
    Intervention Description
    monthly intravitreal injections
    Intervention Type
    Drug
    Intervention Name(s)
    Pranoprofen
    Intervention Description
    0.1% pranoprofen 3 times a day topical eye drops administration
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Carotenoids
    Intervention Description
    daily supplementation of nutraceutical tablets containing the AREDS2 formulation
    Primary Outcome Measure Information:
    Title
    Central Retinal Thickness (microns)
    Description
    Optical Coherence Tomography will be used to assess central retinal thickness.
    Time Frame
    12-month
    Title
    Visual Acuity (LogMAR)
    Description
    ETDRS charts will be used to assess best corrected visual acuity
    Time Frame
    12-month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22840421
    Citation
    AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.
    Results Reference
    background
    PubMed Identifier
    24310343
    Citation
    Age-Related Eye Disease Study 2 (AREDS2) Research Group; Chew EY, Clemons TE, Sangiovanni JP, Danis RP, Ferris FL 3rd, Elman MJ, Antoszyk AN, Ruby AJ, Orth D, Bressler SB, Fish GE, Hubbard GB, Klein ML, Chandra SR, Blodi BA, Domalpally A, Friberg T, Wong WT, Rosenfeld PJ, Agron E, Toth CA, Bernstein PS, Sperduto RD. Secondary analyses of the effects of lutein/zeaxanthin on age-related macular degeneration progression: AREDS2 report No. 3. JAMA Ophthalmol. 2014 Feb;132(2):142-9. doi: 10.1001/jamaophthalmol.2013.7376.
    Results Reference
    background

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    Nutraceutical Support With Omega-3

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