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

Age Related Macular Degeneration Clinical Trial

Official title:

SOD as Antioxidant Treatment OF ARMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800995
• Other study ID #: CHUG-0501
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2008
• Last updated: December 2, 2008
• Start date: September 2005
• Est. completion date: June 2008

Study information

• Verified date: December 2008
• Source: Centre de Recherche en Nutrition Humaine Rhone-Alpe
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• unilateral neo-vascular ARMD

Exclusion Criteria:

• other pathology

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Dietary Supplement:
• SOD

• Sham

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche en Nutrition Humaine Rhone-Alpe

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference on AREDS score, Month 24 - Month 0		24 months	No