Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

Amblyopia Clinical Trial

— ATS14  

Official title:

A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17 Year Olds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789672
• Other study ID #: NEI-141
• Secondary ID: 2U10EY011751
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2008
• Last updated: July 7, 2016
• Start date: January 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2016
• Source: Jaeb Center for Health Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This pilot study is being conducted as a prelude to a randomized trial to compare levodopa/carbidopa plus patching versus patching alone. The purpose of the pilot study is to demonstrate recruitment potential, to provide prospective data on the tolerability of levodopa as a treatment for amblyopia, to provide limited data on its safety, to provide limited data on it's efficiency, and to provide data to assist in selecting a dose to use in a subsequent phase 3 randomized trial. In addition, this study will provide the opportunity for investigators to gain experience in using levodopa prior to a randomized trial.

Description:

Amblyopia is the most common cause of monocular visual impairment in both children and young and middle-aged adults. Both patching and atropine are accepted treatment modalities for the management of moderate amblyopia in children. Despite best efforts with conventional amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal visual acuity in the amblyopic eye. In a previous PEDIG study (ATS3) where children 7 to 13 years old were treated with atropine and patching, only 36% of the children with moderate amblyopia and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Age 8 to < 18 years old

• Amblyopia associated with strabismus, anisometropia, or both

• Visual acuity in the amblyopic eye 18 to 67 letters inclusive (20/50 to 20/400)

• Visual acuity in the sound eye = 78 letters (20/25 or better)

• Current amblyopia treatment of at least 2 hours patching per day

• No improvement 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.

Exclusion Criteria:

• Myopia more than -6.00 D (spherical equivalent) in either eye.

• Current vision therapy or orthoptics

• Ocular cause for reduced visual acuity

• nystagmus per se does not exclude the subject if the above visual acuity criteria are met

• Prior intraocular or refractive surgery

• History of narrow-angle glaucoma

• Strabismus surgery planned within 16 weeks

• Known allergy to levodopa-carbidopa

• History of dystonic reactions

• Current requirement to take oral iron supplements including multivitamins containing iron during the 8 weeks of treatment with levodopa-carbidopa

• Current use of antihypertensive, anti-depressant medications, phenothiazines, butyrophenones, risperidone and isoniazid, non-specific monoamine oxidase inhibitors

• Current use of medication for the treatment of attention deficit hyperactivity disorder

• Known gastrointestinal or liver disease

• History of melanoma

• Known psychological problems

• Known skin reactions to patch or bandage adhesives

• Prior levodopa treatment

• Current treatment with topical atropine

• Females who are pregnant, lactating, or intending to become pregnant within the next 16 weeks.

• A negative urine pregnancy test will be required for all females who have experienced menarche.

• Requirements regarding the establishment of pregnancy and monitoring of pregnancy over the course of the study as defined by each individual Institutional Review Board may supersede these criteria.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amblyopia

Intervention

Drug:
• levodopa/carbidopa
Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation)

Device:
• patching
2 hours daily patching

Drug:
• levodopa/carbidopa
Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)

Locations

Country	Name	City	State
United States	Wilmer Eye Institute	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Repka MX, Kraker RT, Beck RW, Atkinson CS, Bacal DA, Bremer DL, Davis PL, Gearinger MD, Glaser SR, Hoover DL, Laby DM, Morrison DG, Rogers DL, Sala NA, Suh DW, Wheeler MB; Pediatric Eye Disease Investigator Group. Pilot study of levodopa dose as treatment — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).	9 weeks after starting levodopa	No
Primary	Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 being the best.	9 weeks after starting levodopa	No
Primary	Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	baseline to 9 weeks	No
Primary	Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	baseline to 9 weeks	No
Primary	Tolerability of Study Medication-Adverse Event Reporting	Number of adverse events reported throughout entire study.	24 weeks	Yes
Secondary	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).	4 weeks after enrollment	No
Secondary	Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.	4 weeks after enrollment	No
Secondary	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. Letter scores are presented as Snellen Equivalents for presentation (i.e. 20/20 includes those with letter scores between 83 and 87 letters, 20/25 includes those with letter scores between 78 to 82 letters, etc.).	10 weeks after stopping levodopa	No
Secondary	Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best.	10 weeks after stopping levodopa	No
Secondary	Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	enrollment to 4 weeks	No
Secondary	Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	enrollment to 4 weeks	No
Secondary	Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	baseline to 10 weeks after stopping levodopa	No
Secondary	Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa	Visual acuity was measured with the electronic early treatment diabetic retinopathy study (E-ETDRS) method and resulted in a letter score that could range from 0 to 97 letters, with 0 being the worst and 97 the best. A difference was calculated as the difference in letters between baseline and outcome with positive difference indicating improvement in acuity.	baseline to 10 weeks after stopping levodopa	No