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

Phase 3

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Dietary Supplement: Sham; Dietary Supplement: SOD

• Registration Number: NCT00800995
• Lead Sponsor: Centre de Recherche en Nutrition Humaine Rhone-Alpe

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2008-04
• Study Completion: 2008-06
• Status Verified: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Last Update Submitted: 2008-12-02
• Study First Posted: 2008-12-03
• Last Update Posted: 2008-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• unilateral neo-vascular ARMD

Exclusion Criteria

• other pathology

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Sham	-
SOD	SOD	-

Primary Outcome Measures

Name	Time	Method
difference on AREDS score, Month 24 - Month 0	24 months

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Grenoble; 🇫🇷 Grenoble, France