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

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. Identifier: NCT00800995
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : December 3, 2008
Information provided by:
Centre de Recherche en Nutrition Humaine Rhone-Alpe

Brief Summary:


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 or disease Intervention/treatment Phase
Age Related Macular Degeneration Dietary Supplement: SOD Dietary Supplement: Sham Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
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
Study Start Date : September 2005
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Control Dietary Supplement: Sham
Experimental: SOD Dietary Supplement: SOD

Primary Outcome Measures :
  1. difference on AREDS score, Month 24 - Month 0 [ Time Frame: 24 months ]

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

Inclusion Criteria:

  • unilateral neo-vascular ARMD

Exclusion Criteria:

  • other pathology

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 identifier (NCT number): NCT00800995

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

Responsible Party: Pr Romanet, CHU Grenoble Identifier: NCT00800995     History of Changes
Other Study ID Numbers: CHUG-0501
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: December 2008

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

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