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

This study has been completed.
Sponsor:
Information provided by:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
ClinicalTrials.gov Identifier:
NCT00800995
First received: December 2, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration
 Dietary Supplement: SOD
Dietary Supplement: Sham
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SOD as Antioxidant Treatment OF ARMD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre de Recherche en Nutrition Humaine Rhone-Alpe:

Primary Outcome Measures:
  • difference on AREDS score, Month 24 - Month 0 [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: September 2005
Study Completion Date: June 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control Dietary Supplement: Sham
Experimental: SOD Dietary Supplement: SOD

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral neo-vascular ARMD

Exclusion Criteria:

  • other pathology
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800995

Locations
France
Centre Hospitalier Universitaire de Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
Centre de Recherche en Nutrition Humaine Rhone-Alpe
  More Information

No publications provided

Responsible Party: Pr Romanet, CHU Grenoble
ClinicalTrials.gov Identifier: NCT00800995     History of Changes
Other Study ID Numbers: CHUG-0501
Study First Received: December 2, 2008
Last Updated: December 2, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre de Recherche en Nutrition Humaine Rhone-Alpe:
ARMD
SOD

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Antioxidants
Superoxide Dismutase
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers

ClinicalTrials.gov processed this record on May 21, 2013