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

December 2, 2008 updated by: Centre de Recherche en Nutrition Humaine Rhone-Alpe

SOD as Antioxidant Treatment OF ARMD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire de Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • unilateral neo-vascular ARMD

Exclusion Criteria:

  • other pathology

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control
Dietary supplement: Sham
EXPERIMENTAL: SOD
Dietary supplement: SOD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference on AREDS score, Month 24 - Month 0
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche en Nutrition Humaine Rhone-Alpe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (ESTIMATE)

December 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 3, 2008

Last Update Submitted That Met QC Criteria

December 2, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUG-0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe