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Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

Primary Purpose

Amblyopia

Status

Not yet recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Docosahexaenoic Acid

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Amblyopia focused on measuring Docosahexaenoic acid, Long chain fatty acid

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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

Sites / Locations

Johns Hopkins Hospital, Wilmer Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Docosahexaenoic acid (DHA) arm

Placebo arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Visual acuity response with DHA

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03402789

First Posted

January 11, 2018

Last Updated

January 23, 2023

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT03402789

Brief Title

Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

Official Title

Pilot Study to Evaluate Docosahexaenoic Acid as Treatment for Residual Amblyopia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 1, 2024 (Anticipated)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Amblyopia

Keywords

Docosahexaenoic acid, Long chain fatty acid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

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

Participant

Masking Description

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.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Docosahexaenoic acid (DHA) arm

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Docosahexaenoic Acid

Other Intervention Name(s)

DHA

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

Placebo tablet daily plus 2 hours of eye patching daily

Primary Outcome Measure Information:

Title

Visual acuity response with DHA

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Courtney Kraus, MD

Phone

410-955-5492

ckraus6@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Angeline M Nguyen, MD

Phone

972-767-9852

anguye24@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Courtney Kraus, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Hospital, Wilmer Eye Institute

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287-9028

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Courtney Kraus, MD

Phone

410-955-5492

ckraus6@jhmi.edu

First Name & Middle Initial & Last Name & Degree

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

25676904

Citation

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.

Results Reference

background

PubMed Identifier

27995607

Citation

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.

Results Reference

background

PubMed Identifier

11687076

Citation

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.

Results Reference

background

PubMed Identifier

17688705

Citation

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.

Results Reference

background

PubMed Identifier

23877090

Citation

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.

Results Reference

background

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Docosahexaenoic Acid (DHA) Supplementation in Amblyopia

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