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AmblyopiaPhase 1/2NCT03402789

Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

A Phase 1/2 study testing Docosahexaenoic Acid in people with Amblyopia, run by Johns Hopkins University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study evaluates the addition of docosahexaenoic acid (DHA) to eye patching in the treatment of residual amblyopia in children ages 3 to 18 years old. Two thirds of participants will receive DHA along with eye patching, while one third of participants will receive a placebo along with eye patching. Read more about this study

Who is it for?
Ages 3 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Amblyopia
What is being tested?
Docosahexaenoic Acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2024to 30 Dec 2024
Phase
Phase 1/2
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 3 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age 3 to < 18 years
  • Amblyopia associated with strabismus, anisometropia, or both
  • Visual acuity, measured in each eye (without cycloplegia) within 7 days prior to enrollment using letter matching or the ETDRS protocol as follows:
  • Visual acuity in the amblyopic eye of 20/50 to 20/400
  • Visual acuity in the sound eye of 20/25 or better
  • No improvement or decline in best-corrected amblyopic eye visual acuity between two consecutive visits at least 4 weeks apart using the same testing method and optimal spectacle correction (if needed), with no improvement of more than 4 letters or one logMAR line.
Show all 11Show fewer
  • Previous or current treatment of amblyopia with either patching or atropine drops
  • Spectacle correction (if applicable) for measurement of enrollment visual acuity must meet the following criteria and be based on a cycloplegic refraction that is no more than 6 months old
  • Ocular examination within 6 months prior to enrollment
  • Parent available for at least 6 months of follow-up, has home phone (or access to phone), and willing to be contacted by clinical site staff
  • In the investigator's judgment, the subject is likely to comply with prescribed treatment (e.g., no history of poor compliance with patching treatment).

Who cannot join

  • Myopia more than -8.00 D (spherical equivalent) in either eye.
  • Current vision therapy or orthoptics
  • Ocular cause for reduced visual acuity
  • Prior intraocular or refractive surgery
  • Strabismus surgery planned within 6 months
  • Known immunodeficiency or hypercoagulable state
Show all 10Show fewer
  • Known skin reactions to patch or bandage adhesives
  • Current treatment with topical atropine
  • Constant deviations larger than 35 prism diopters
  • Patients whose guardians have significant language or hearing impairment that would inhibit them from understanding the consent form or the procedures of the study will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital, Wilmer Eye Institute

    Baltimore, Maryland, 21287-9028

Other trials in United States

About this study

Official title: Pilot Study to Evaluate Docosahexaenoic Acid as Treatment for Residual Amblyopia

This study evaluates the addition of docosahexaenoic acid (DHA) to eye patching in the treatment of residual amblyopia in children ages 3 to 18 years old. Two thirds of participants will receive DHA along with eye patching, while one third of participants will receive a placebo along with eye patching.

Read the detailed description

Amblyopia is the most common cause of monocular visual impairment in children and adults. There are well established therapies for this condition, which typically involve eye patching or atropine eye drops. Despite these therapies, a substantial proportion of treated patients have some degree of residual amblyopia, even when treatment takes place early during the critical period visual development.

Investigators have tried to augment standard amblyopia treatment with medications that appear to promote visual cortex plasticity, thus addressing the neuronal pathogenesis of amblyopia. For example, levodopa, was described as a possible drug to treat amblyopia due to its ability to enhance cortical plasticity. While the rationale behind such treatments is promising, results from well-powered clinical trials have not shown a statistically significant effect of these treatments.

Docosahexaenoic acid (DHA) is a long chain polyunsaturated fatty acid (LCPUFA) that is considered essential for the maturation of the developing brain and retina. DHA, which is commercially available a nutritional supplement, has been added to infant formula, with studies showing that it improves visual development in premature infants. Randomized studies have shown that DHA supplementation of infant formula results in higher visual acuity in infants. Our proposal is aimed at conducting a prospective randomized pilot study to provide a preliminary assessment of the efficacy and safety of DHA combined with daily ocular occlusion therapy in children and teenagers with residual amblyopia. To our knowledge, this would be the first study aiming to treat amblyopia with DHA. If found to be effective, DHA may be considered a safe and inexpensive adjunct to our conventional means of treating amblyopia.

Conditions
Amblyopia
Being tested
Docosahexaenoic Acid, Placebo Oral Tablet
Keywords
Docosahexaenoic acid, Long chain fatty acid
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docosahexaenoic AcidDrug

    Also called DHA

    Docosahexaenoic acid 1,200mg daily plus 2 hours of eye patching daily

  • Placebo Oral TabletDrug

    Placebo tablet daily plus 2 hours of eye patching daily

Study groups in NCT03402789
Study groupRoleWhat they receive
Docosahexaenoic acid (DHA) armExperimentalParticipants will receive a pill of docosahexaenoic acid 1,200mg daily in addition to 2 hours of daily eye patching of the affected eye.
Receives: Drug: Docosahexaenoic Acid
Placebo armPlacebo comparatorParticipants will receive a placebo pill daily in addition to 2 hours of daily eye patching of the affected eye.
Receives: Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual acuity response with DHA

    Measurement of the visual acuity change in those in the DHA arm compared to the placebo arm

    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 posted18 Jan 2018
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jul 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Why it stopped: Hopkins failed to review contract with company providing complimentary dha, support was withdrawn necessitating me to get more grant money to fund study which was unsucccessful.

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
single blinded randomized controlled pilot study with 2/3 of participants randomized into the treatment arm and 1/3 of participants randomized into the placebo arm.
Masking
Single blind
Who is masked
Participant
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03402789
Sponsor's protocol ID
IRB00150865
Status last verified
Feb 2024
First submitted
11 Jan 2018
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pediatric Eye Disease Investigator Group; Repka MX, Kraker RT, Dean TW, Beck RW, Siatkowski RM, Holmes JM, Beauchamp CL, Golden RP, Miller AM, Verderber LC, Wallace DK. A randomized trial of levodopa as treatment for residual amblyopia in older children. Ophthalmology. 2015 May;122(5):874-81. doi: 10.1016/j.ophtha.2015.01.002. Epub 2015 Feb 9.

    PubMed 25676904

  • Moon K, Rao SC, Schulzke SM, Patole SK, Simmer K. Longchain polyunsaturated fatty acid supplementation in preterm infants. Cochrane Database Syst Rev. 2016 Dec 20;12(12):CD000375. doi: 10.1002/14651858.CD000375.pub5.

    PubMed 27995607

  • Simmer K. Long-chain polyunsaturated fatty acid supplementation in infants born at term. Cochrane Database Syst Rev. 2001;(4):CD000376. doi: 10.1002/14651858.CD000376.

    PubMed 11687076

  • Koletzko B, Cetin I, Brenna JT; Perinatal Lipid Intake Working Group; Child Health Foundation; Diabetic Pregnancy Study Group; European Association of Perinatal Medicine; European Association of Perinatal Medicine; European Society for Clinical Nutrition and Metabolism; European Society for Paediatric Gastroenterology, Hepatology and Nutrition, Committee on Nutrition; International Federation of Placenta Associations; International Society for the Study of Fatty Acids and Lipids. Dietary fat intakes for pregnant and lactating women. Br J Nutr. 2007 Nov;98(5):873-7. doi: 10.1017/S0007114507764747. Epub 2007 Aug 10.

    PubMed 17688705

  • Kuratko CN, Barrett EC, Nelson EB, Salem N Jr. The relationship of docosahexaenoic acid (DHA) with learning and behavior in healthy children: a review. Nutrients. 2013 Jul 19;5(7):2777-810. doi: 10.3390/nu5072777.

    PubMed 23877090

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Docosahexaenoic Acid in people with Amblyopia, run by Johns Hopkins University 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 11 inclusion and 10 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: withdrawn, as of the sponsor's last update on 9 Feb 2024. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Visual acuity response with DHA (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 NCT03402789, which also lists 5 linked publications.

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 9 Feb 2024.

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