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

NCT ID: NCT02264938

Last Updated: 2014-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Observation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Antioxidant

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.

Group Type ACTIVE_COMPARATOR

Antioxidant

Intervention Type DIETARY_SUPPLEMENT

Oral supplemmentation with antioxidants

Interventions

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Antioxidant

Oral supplemmentation with antioxidants

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* AREDS category 2 and 3 AMD

Exclusion Criteria

* AREDS category 4 AMD
* other ophthalmological diseases
* currently on antioxidant supplementation
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xavier Valldeperas

MD, PhD, FEBO

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.

Reference Type DERIVED
PMID: 37702300 (View on PubMed)

Other Identifiers

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AC-11-112

Identifier Type: -

Identifier Source: org_study_id

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