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

Primary Purpose

Age Related Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
SOD
Sham
Sponsored by
Centre de Recherche en Nutrition Humaine Rhone-Alpe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age Related Macular Degeneration focused on measuring ARMD, SOD

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral neo-vascular ARMD

Exclusion Criteria:

  • other pathology

Sites / Locations

  • Centre Hospitalier Universitaire de Grenoble

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

SOD

Arm Description

Outcomes

Primary Outcome Measures

difference on AREDS score, Month 24 - Month 0

Secondary Outcome Measures

Full Information

First Posted
December 2, 2008
Last Updated
December 2, 2008
Sponsor
Centre de Recherche en Nutrition Humaine Rhone-Alpe
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1. Study Identification

Unique Protocol Identification Number
NCT00800995
Brief Title
Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD)
Official Title
SOD as Antioxidant Treatment OF ARMD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre de Recherche en Nutrition Humaine Rhone-Alpe

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
ARMD, SOD

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Title
SOD
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
SOD
Intervention Type
Dietary Supplement
Intervention Name(s)
Sham
Primary Outcome Measure Information:
Title
difference on AREDS score, Month 24 - Month 0
Time Frame
24 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral neo-vascular ARMD Exclusion Criteria: other pathology
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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