Age Related Macular DegenerationPhase 3NCT00800995
Superoxide Dismutase (SOD) as Antioxidant Treatment OF Age Related Macular Degeneration (ARMD)
A Phase 3 study testing SOD in people with Age Related Macular Degeneration, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- SOD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- unilateral neo-vascular ARMD
Who cannot join
- other pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SOD as Antioxidant Treatment OF ARMD
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.
- Conditions
- Age Related Macular Degeneration
- Being tested
- SOD, Sham
- Keywords
- ARMD, SOD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SODDietary supplement
ShamDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Not described Receives: Dietary Supplement: Sham |
| SOD | Experimental | Not described Receives: Dietary Supplement: SOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference on AREDS score, Month 24 - Month 0
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startSep 2005
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800995
- Sponsor's protocol ID
- CHUG-0501
- Status last verified
- Dec 2008
- First submitted
- 2 Dec 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOD as Antioxidant Treatment OF ARMD
- ClinicalTrials.gov ID
- NCT00800995
- Acronym / sponsor ID
- CHUG-0501
- Conditions
- Age Related Macular Degeneration
- Keywords
- ARMD, SOD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-AlpeUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Dietary Supplement: Sham |
| SOD | Experimental | Dietary Supplement: SOD |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- unilateral neo-vascular ARMD
Key exclusion criteria (1 listed)
- other pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOD | Dietary supplement | SOD |
| Sham | Dietary supplement | Control |
Primary outcome
difference on AREDS score, Month 24 - Month 0
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SOD in people with Age Related Macular Degeneration, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference on AREDS score, Month 24 - Month 0 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2008.