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Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antioxidant
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AREDS category 2 and 3 AMD

Exclusion Criteria:

  • AREDS category 4 AMD
  • other ophthalmological diseases
  • currently on antioxidant supplementation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Observation

    Antioxidant

    Arm Description

    Patients with AREDS category 2 and 3 AMD are observed during 1 year

    Patients with AREDS category 2 and 3 AMD are enrolled to take daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg) during 1 year.

    Outcomes

    Primary Outcome Measures

    Drusen volume change

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2014
    Last Updated
    October 9, 2014
    Sponsor
    Germans Trias i Pujol Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02264938
    Brief Title
    Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation
    Official Title
    Drusen Morphology Changes in Nonexudative Age-related Degeneration Using Spectral Domain Optical Coherence Tomography After Oral Antioxidants Supplementation: One-year Results.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Germans Trias i Pujol Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Purpose: To determine drusen morphology (volume and area) changes in nonexudative age-related macular degeneration (AMD) after one year of oral supplementation with AREDS-like formulation.
    Detailed Description
    Methods: Patients with AREDS category 2 and 3 AMD were prospectively enrolled in this study, and were randomized to receive daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg), or observation during one year. ETDRS vision, biomicroscopy, intraocular pressure (IOP), color fundus photography and automatic measurement of drusen with Topcon 3D-OCT 2000 (Topcon, Tokyo, Japan) using the 6 x 6 mm 3D cube scan protocol, were performed in all patients, at baseline and 12 months after. Automated delineation of macular drusen was modified by the investigators when evident segmentation errors occurred.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    35 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Observation
    Arm Type
    No Intervention
    Arm Description
    Patients with AREDS category 2 and 3 AMD are observed during 1 year
    Arm Title
    Antioxidant
    Arm Type
    Active Comparator
    Arm Description
    Patients with AREDS category 2 and 3 AMD are enrolled to take daily oral supplementation with lutein (12mg) + zeaxanthin (2mg) + astaxanthin (8mg) + omega-3 fatty acids (docosahexaenoic acid [DHA] 540mg + eicosapentaenoic acid [EPA] 360mg) + vitamin C (40mg) + vitamin E (20mg) + zinc (16mg) + copper (2mg) during 1 year.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Antioxidant
    Intervention Description
    Oral supplemmentation with antioxidants
    Primary Outcome Measure Information:
    Title
    Drusen volume change
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: AREDS category 2 and 3 AMD Exclusion Criteria: AREDS category 4 AMD other ophthalmological diseases currently on antioxidant supplementation

    12. IPD Sharing Statement

    Learn more about this trial

    Drusen Morphology Changes in Nonexudative Age-related Degeneration After Oral Antioxidants Supplementation

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