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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800995
First Posted: December 3, 2008
Last Update Posted: December 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre de Recherche en Nutrition Humaine Rhone-Alpe
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SOD as Antioxidant Treatment OF ARMD

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unilateral neo-vascular ARMD

Exclusion Criteria:

  • other pathology
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00800995


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

Responsible Party: Pr Romanet, CHU Grenoble
ClinicalTrials.gov Identifier: NCT00800995     History of Changes
Other Study ID Numbers: CHUG-0501
First Submitted: December 2, 2008
First Posted: December 3, 2008
Last Update Posted: December 3, 2008
Last Verified: December 2008

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
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers