AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in United States

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.

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 groups in NCT01258335
Study groupRoleWhat they receive
Omega 3 Fatty acidsActive comparatorII. 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 OilPlacebo comparatorii. 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.

  1. 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.

  1. First posted10 Dec 2010 (estimated)
  2. Study startOct 2008
  3. Primary completionNov 2010
  4. Study completionNov 2010

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in