Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD)

NCT ID: NCT00800995

Last Updated: 2008-12-03

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

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-06-30

Brief Summary

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INTRODUCTION:

Acting directly on the anti-radical enzyme chain, the superoxide dismutase (SOD), a major enzyme of the anti-oxidant system, provides an alternative of the antioxidants treatment in ARMD. Its synthesis depends on the cellular oxygenated reactive species, and leads to the conversion of the superoxide ion (O2-) into hydrogen peroxide (H2O2). This compound is the cell watch guard continuously regulating a free radicals' detoxifying chain. Subsequently, by increasing the production of H2O2, the administration of SOD can trigger endogenous/internal antioxidant mechanisms.

Oral administration of SOD is possible in its galenic form, Glisodine. The purpose of this study was to evaluate the protective effect of SOD on the bilateralization of the disease.

Detailed Description

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Conditions

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Age Related Macular Degeneration

Keywords

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ARMD SOD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type SHAM_COMPARATOR

Sham

Intervention Type DIETARY_SUPPLEMENT

SOD

Group Type EXPERIMENTAL

SOD

Intervention Type DIETARY_SUPPLEMENT

Interventions

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SOD

Intervention Type DIETARY_SUPPLEMENT

Sham

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* unilateral neo-vascular ARMD

Exclusion Criteria

* other pathology
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre de Recherche en Nutrition Humaine Rhone-Alpe

OTHER

Sponsor Role lead

Responsible Party

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CHU Grenoble

Locations

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Centre Hospitalier Universitaire de Grenoble

Grenoble, , France

Site Status

Countries

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France

Other Identifiers

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CHUG-0501

Identifier Type: -

Identifier Source: org_study_id