AMDAGEDNCT02625376
Resveratrol for Exudative Age-Related Macular Degeneration
A study testing Resvega and Trans-Resveratrol in people with AMD and Age-related Macular Degeneration, run by Poitiers University Hospital at 1 site in France.
Trial summary
This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- AMD, Age-related Macular Degeneration, Choroidal Neovascularisation
- What is being tested?
- Resvega and Trans-Resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 6 Aug 2015to 9 Nov 2016
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 55 or more with unilateral exudative AMD
- Visual acuity less or equal to 20/25 in the most affected eye
Who cannot join
- Allergy to an investigational product
- atrophic Age-Related Macular Degeneration or age related maculopathy
- significant media opacities
- Other retinal pathology (diabetic retinopathy, high myopia, retinal dystrophy)
- Recent Cataract surgery
- Previous history of vitrectomy
- Acute or chronic severe organ failure
- Present participation in other clinical research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.
This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.
Read the detailed description
Interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.
Comparison of incidence of choroidal neaovascularization between each study group will be performed.
- Being tested
- Resvega, Trans-Resveratrol, placebo
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResvegaDietary supplement
Dietary supplementation with Resvega BD
Trans-ResveratrolDietary supplement
Dietary supplementation with resveratrol 250 mg BD
placeboDietary supplement
Dietary supplementation with a placebo BD
| Study group | Role | What they receive |
|---|---|---|
| Trans-Resveratrol | Experimental | capsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months Receives: Dietary Supplement: Trans-Resveratrol |
| Resvega | Active comparator | capsule composed of antioxydant, omega 3, carotenoid, 15 mg of resveratrol, zinc and copper.
two capsules daily : one in the morning and evening for 24 months Receives: Dietary Supplement: Resvega |
| Placebo | Placebo comparator | capsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months
What is the influence of the daily intake of 500 mg of resveratrol on the incidence of neovascularization of the second eye?
Measured: 24 months
Secondary outcomes (1)
Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months
What is the influence of the daily intake resvega on the incidence of neovascularization of the second eye?
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 posted9 Dec 2015 (estimated)
- Study start6 Aug 2015
- Primary completion26 Oct 2016
- Study completion9 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AMDStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas LEVEZIEL, MD, PhD, Principal investigator, Dpt of Ophthalmology, University Hospital of Poitiers, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625376
- Sponsor's protocol ID
- AGED/EudraCT : 2015-001577-41
- Acronym
- AGED
- Status last verified
- May 2020
- First submitted
- 6 Aug 2015
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
PubMed 37702300
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Resveratrol and Resvega Versus Placebo on Incidence of Bilateralisation of Exudative AMD: a Double Masked Prospective Study.
- ClinicalTrials.gov ID
- NCT02625376
- Acronym / sponsor ID
- AGED / AGED/EudraCT : 2015-001577-41
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 6 Aug 2015 (actual)
- Primary completion
- 26 Oct 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 9 Dec 2015 (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.
This is an interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.
Detailed description
Interventional, prospective, randomized, comparative monocentric study aiming to evaluate the safety and efficacy of Resveratrol to reduce the progression of exudative Age-Related Macular Degeneration.
Comparison of incidence of choroidal neaovascularization between each study group will be performed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trans-Resveratrol | Experimental | Dietary Supplement: Trans-Resveratrolcapsule of 250 mg of resveratrol. two capsules daily : one in the morning and evening for 24 months |
| Resvega | Active comparator | Dietary Supplement: Resvegacapsule composed of antioxydant, omega 3, carotenoid, 15 mg of resveratrol, zinc and copper. two capsules daily : one in the morning and evening for 24 months |
| Placebo | Placebo comparator | Dietary Supplement: placebocapsule of medium chain triglyceride. two capsules daily : one in the morning and evening for 24 months |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women aged 55 or more with unilateral exudative AMD
- Visual acuity less or equal to 20/25 in the most affected eye
Key exclusion criteria (8 listed)
- Allergy to an investigational product
- atrophic Age-Related Macular Degeneration or age related maculopathy
- significant media opacities
- Other retinal pathology (diabetic retinopathy, high myopia, retinal dystrophy)
- Recent Cataract surgery
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 |
|---|---|---|
| ResvegaDietary supplementation with Resvega BD | Dietary supplement | Resvega |
| Trans-ResveratrolDietary supplementation with resveratrol 250 mg BD | Dietary supplement | Trans-Resveratrol |
| placeboDietary supplementation with a placebo BD | Dietary supplement | Placebo |
Primary outcome
Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months
Time frame: 24 months
What is the influence of the daily intake of 500 mg of resveratrol on the incidence of neovascularization of the second eye?
1 secondary outcome
Comparaison of incidence of choroidal neovascularization between Resvega group and placebo group at 24 months
Time frame: 24 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 37702300Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023 Sep 13;9(9):CD000254. doi: 10.1002/14651858.CD000254.pub5.
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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.
Nicolas LEVEZIEL, MD, PhD principal investigator
Dpt of Ophthalmology, University Hospital of Poitiers, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resvega and Trans-Resveratrol in people with AMD and Age-related Macular Degeneration, run by Poitiers University Hospital 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 1 Jun 2020. 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.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Comparaison of incidence of choroidal neovascularization between resveratrol group and placebo group at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625376, which also lists 1 linked publication.
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 1 Jun 2020.