Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

NCT03402789 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: IRB00150865
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amblyopia

Keywords

Docosahexaenoic acid; Long chain fatty acid

Outcome Measures

Primary Outcomes (1)

• Visual acuity response with DHA

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

  6 months

Study Arms (2)

Docosahexaenoic acid (DHA) arm

EXPERIMENTAL

Participants will receive a pill of docosahexaenoic acid 1,200mg daily in addition to 2 hours of daily eye patching of the affected eye.

Drug: Docosahexaenoic Acid

Placebo arm

PLACEBO COMPARATOR

Participants will receive a placebo pill daily in addition to 2 hours of daily eye patching of the affected eye.

Drug: Placebo Oral Tablet

Interventions

Docosahexaenoic Acid DRUG

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

Also known as: DHA

Docosahexaenoic acid (DHA) arm

Placebo Oral Tablet DRUG

Placebo tablet daily plus 2 hours of eye patching daily

Placebo arm

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital, Wilmer Eye Institute

Baltimore, Maryland, 21287-9028, United States

Location

Related Publications (5)

• 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.

  PMID: 25676904 BACKGROUND

• 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.

  PMID: 27995607 BACKGROUND

• 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.

  PMID: 11687076 BACKGROUND

• 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.

  PMID: 17688705 BACKGROUND

• 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.

  PMID: 23877090 BACKGROUND

MeSH Terms

Conditions

Amblyopia

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Officials

• Courtney Kraus, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not be informed of whether they are taking the treatment drug or the placebo. Technicians measuring participants' visual outcomes are also masked. The principal investigator and co-investigators will know how the patient's are randomized.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: January 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 30, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)