Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD)
SOD as Antioxidant Treatment OF ARMD
1 other identifier
interventional
46
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 3, 2008
CompletedDecember 3, 2008
December 1, 2008
2.6 years
December 2, 2008
December 2, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
difference on AREDS score, Month 24 - Month 0
24 months
Study Arms (2)
Control
SHAM COMPARATORSOD
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- unilateral neo-vascular ARMD
You may not qualify if:
- other pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38043, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 3, 2008
Study Start
September 1, 2005
Primary Completion
April 1, 2008
Study Completion
June 1, 2008
Last Updated
December 3, 2008
Record last verified: 2008-12