Aged Macular DegenerationOmega 3NCT01258335
Omega-3-fatty Acids on Age-related Macular
A study testing Omega 3 and Olive Oil in people with Aged Macular Degeneration, run by Mid Atlantic Retina at 1 site in United States.
Trial summary
Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD). Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged Macular Degeneration
- What is being tested?
- Omega 3 and Olive Oil
- 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 siteUnited States
- Study dates
- Oct 2008to Nov 2010
- 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- >49 year old women and men for the dry AMD arms. >20 year old for the normal retina arm.
- 1. No specific race/ethnic background requirements
Who cannot join
- For dry AMD groups, all patients will be included, regardless of prior or concomitant treatment, and regardless of stage of disease.
- Patients already taking omega-3-fatty acids will be excluded. iii. Women of childbearing age with positive urine pregnancy tests or with plans to conceive during the six month study period will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
About this study
Official title: Short Term Ocular Safety Assessment of High Dose Omega-3 Supplementation for Age-Related Macular Degeneration.
Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD).
Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.
Read the detailed description
There is a growing amount of basic science data supporting the use of omega 3 fatty acids in AMD. Koto et al. report that eicosapentaenoic acid, a major omega-3 polyunsaturated fatty acid, prevents CNVM in mice. Conner et al. report in Nature Medicine that increased dietary intake of omega-3-polyunsaturated fatty acids reduces pathological retinal angiogenesis in mice. Miyauchi et al. looked at ERG outcomes in rabbits. They report that an intraperitoneal injection of docosahexaenoic acid given 5 hours before IOP induced ischemia resulted in better ERG amplitudes than controls. Docosahexaenoic acid appears to protect against transient retinal ischemia.
Clinical data on this topic is scarce. A systemic review was published in Retina in 2007 (Hodge, et al.) outlining the limited data. A recent meta-analysis by Chong et al. of nine studies found a high dietary intake of omega-3 fatty acids decreased risk of late AMD by 38%, though the current literature is insufficient to support routine consumption to prevent AMD. Scorolli et al. conducted a randomized control trial on 35 bilateral wet AMD patients receiving photodynamic therapy with our without vitamin E, linolenic acid, alpha-linolenic acid, and docosahexaenoic acid (DHA). The latter two are omega-3-fatty acids. Patients in the polyunsaturated fatty acid (PUFA) group had significantly shorter recovery time after macular flash. Visually acuity was not statistically different between the two groups. Feher et al. conducted a randomized control trial using acetyl-L-carnitine, omega-3 fatty acids, and coenzyme Q10 (Phototrop). They report findings that strongly suggest that an appropriate combination of compounds that affect mitochondrial lipid metabolism may improve and subsequently stabilize visual functions, and it may also improve fundus alterations in patients affected by early AMD. The Blue Mountain Eye Study, a cohort study, reports a regular diet high in omega-3 polyunsaturated fat, especially from fish, seems to protect against early and late ARM. Seddon et al. performed a clinic-based case-control study across five centers, concluding diets high in omega-3 fatty acids and fish are inversely associated with risk for AMD when intake of linoleic acid was low. Augood et al. published a cross-sectional study of 105 cases, reporting eating oily fish at least once per week compared with less than once per week decreased the odds ratio for neovascular AMD by half.
Few authors have evaluated the role of ERG in treating AMD. A recent review by Gerth concludes ERG is an important tool in assessing retinal function in AMD and as an outcome measure. Multifocal ERG, possibly combined with other tests, has the greatest value. Hishihara et al. have evaluated the amplitude and implicit time changes in neovascular AMD using focal macular ERGs.
- Conditions
- Aged Macular Degeneration
- Being tested
- Omega 3, Olive Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3Dietary supplement
Omega-3-fatty acids 4 gm oral daily (Total:840mg EPA/2520mg DHA) (1:3 ratio of EPA to DHA) ( 6 capsules fatty acids)
Olive OilOther
ii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil)
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 Fatty acids | Active comparator | II. Study arms:
a. Participants in the dry AMD study group will be randomized into two arms with a 4:1 ratio: i. Omega-3-fatty acids 4 gm oral daily (Total:840mg EPA/2520mg DHA) (1:3 ratio of EPA to DHA) ( 6 capsules fatty acids) Receives: Dietary Supplement: Omega 3 |
| Olive Oil | Placebo comparator | ii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil) Receives: Other: Olive Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega 3
Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD).
Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startOct 2008
- Primary completionNov 2010
- Study completionNov 2010
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 Aged 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid Atlantic Retina
- Sponsor type
- University, hospital or other
- Collaborators
- LifeGuard
- Investigators
- Allen Ho, MD, Principal investigator, Retina Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258335
- Sponsor's protocol ID
- 08-887
- Acronym
- Omega 3
- Status last verified
- Nov 2011
- First submitted
- 9 Dec 2010
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Gerstenblith AT, Baskin DE, Shah CP, Wolfe JD, Fineman MS, Kaiser RS, Ho AC. Electroretinographic effects of omega-3 Fatty Acid supplementation on dry age-related macular degeneration. JAMA Ophthalmol. 2013 Mar;131(3):365-9. doi: 10.1001/jamaophthalmol.2013.642.
PubMed 23494041
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Ocular Safety Assessment of High Dose Omega-3 Supplementation for Age-Related Macular Degeneration.
- ClinicalTrials.gov ID
- NCT01258335
- Acronym / sponsor ID
- Omega 3 / 08-887
- Conditions
- Aged Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mid Atlantic RetinaUniversity, hospital or other
- Collaborators
- LifeGuard
- Study start
- Oct 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 10 Dec 2010 (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.
Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD).
Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.
Detailed description
There is a growing amount of basic science data supporting the use of omega 3 fatty acids in AMD. Koto et al. report that eicosapentaenoic acid, a major omega-3 polyunsaturated fatty acid, prevents CNVM in mice. Conner et al. report in Nature Medicine that increased dietary intake of omega-3-polyunsaturated fatty acids reduces pathological retinal angiogenesis in mice. Miyauchi et al. looked at ERG outcomes in rabbits. They report that an intraperitoneal injection of docosahexaenoic acid given 5 hours before IOP induced ischemia resulted in better ERG amplitudes than controls. Docosahexaenoic acid appears to protect against transient retinal ischemia.
Clinical data on this topic is scarce. A systemic review was published in Retina in 2007 (Hodge, et al.) outlining the limited data. A recent meta-analysis by Chong et al. of nine studies found a high dietary intake of omega-3 fatty acids decreased risk of late AMD by 38%, though the current literature is insufficient to support routine consumption to prevent AMD. Scorolli et al. conducted a randomized control trial on 35 bilateral wet AMD patients receiving photodynamic therapy with our without vitamin E, linolenic acid, alpha-linolenic acid, and docosahexaenoic acid (DHA). The latter two are omega-3-fatty acids. Patients in the polyunsaturated fatty acid (PUFA) group had significantly shorter recovery time after macular flash. Visually acuity was not statistically different between the two groups. Feher et al. conducted a randomized control trial using acetyl-L-carnitine, omega-3 fatty acids, and coenzyme Q10 (Phototrop). They report findings that strongly suggest that an appropriate combination of compounds that affect mitochondrial lipid metabolism may improve and subsequently stabilize visual functions, and it may also improve fundus alterations in patients affected by early AMD. The Blue Mountain Eye Study, a cohort study, reports a regular diet high in omega-3 polyunsaturated fat, especially from fish, seems to protect against early and late ARM. Seddon et al. performed a clinic-based case-control study across five centers, concluding diets high in omega-3 fatty acids and fish are inversely associated with risk for AMD when intake of linoleic acid was low. Augood et al. published a cross-sectional study of 105 cases, reporting eating oily fish at least once per week compared with less than once per week decreased the odds ratio for neovascular AMD by half.
Few authors have evaluated the role of ERG in treating AMD. A recent review by Gerth concludes ERG is an important tool in assessing retinal function in AMD and as an outcome measure. Multifocal ERG, possibly combined with other tests, has the greatest value. Hishihara et al. have evaluated the amplitude and implicit time changes in neovascular AMD using focal macular ERGs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 Fatty acids | Active comparator | Dietary Supplement: Omega 3II. Study arms: a. Participants in the dry AMD study group will be randomized into two arms with a 4:1 ratio: i. Omega-3-fatty acids 4 gm oral daily (Total:840mg EPA/2520mg DHA) (1:3 ratio of EPA to DHA) ( 6 capsules fatty acids) |
| Olive Oil | Placebo comparator | Other: Olive Oilii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil) |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- >49 year old women and men for the dry AMD arms. >20 year old for the normal retina arm.
- 1. No specific race/ethnic background requirements
Key exclusion criteria (2 listed)
- For dry AMD groups, all patients will be included, regardless of prior or concomitant treatment, and regardless of stage of disease.
- Patients already taking omega-3-fatty acids will be excluded. iii. Women of childbearing age with positive urine pregnancy tests or with plans to conceive during the six month study period will be excluded.
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 |
|---|---|---|
| Omega 3Omega-3-fatty acids 4 gm oral daily (Total:840mg EPA/2520mg DHA) (1:3 ratio of EPA to DHA) ( 6 capsules fatty acids) | Dietary supplement | Omega 3 Fatty acids |
| Olive Oilii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil) | Other | Olive Oil |
Primary outcome
Omega 3
Time frame: 6 months
Aim: To demonstrate the short-term multi focal electroretinogram (mfERG) effect of oral omega-3-fatty acids in the triglyceride form on dry age-related macular degeneration (AMD). Null hypothesis: Omega-3-fatty acids do not affect the mfERGs of patients with dry AMD.
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 22 Nov 2011.
- Derived from this study: PubMed 23494041Gerstenblith AT, Baskin DE, Shah CP, Wolfe JD, Fineman MS, Kaiser RS, Ho AC. Electroretinographic effects of omega-3 Fatty Acid supplementation on dry age-related macular degeneration. JAMA Ophthalmol. 2013 Mar;131(3):365-9. doi: 10.1001/jamaophthalmol.2013.642.
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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.
Allen Ho, MD principal investigator
Retina Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega 3 and Olive Oil in people with Aged Macular Degeneration, run by Mid Atlantic Retina at 1 site in United States.
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 2 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 22 Nov 2011. 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 United States. 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 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?
Omega 3 (time frame: 6 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 NCT01258335, 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 22 Nov 2011.