AmblyopiaPhase 2ATS14NCT00789672
Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia
A Phase 2 study testing levodopa/carbidopa and patching in people with Amblyopia, run by Jaeb Center for Health Research at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Amblyopia
- What is being tested?
- levodopa/carbidopa and patching
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17 Year Olds
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.
Read the detailed 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.
- Conditions
- Amblyopia
- Being tested
- levodopa/carbidopa, patching
- Keywords
- Amblyopia, Patching, Levodopa
- Medical subject headings
- Amblyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levodopa/carbidopaDrug
Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation)
patchingDevice
Also called Coverlet, 3M Opticlude, Ortopad®
2 hours daily patching
levodopa/carbidopaDrug
Oral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation)
| Study group | Role | What they receive |
|---|---|---|
| Lower Dose (3-1) levodopa/carbidopa | Active comparator | Oral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication. Receives: Device: patching; Drug: levodopa/carbidopa |
| Higher Dose (4.5-1) levodopa/carbidopa | Active comparator | Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication. Receives: Drug: levodopa/carbidopa; Device: patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.).
Measured: 9 weeks after starting levodopa
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.
Measured: 9 weeks after starting levodopa
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.
Measured: baseline to 9 weeks
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.
Measured: baseline to 9 weeks
Tolerability of Study Medication-Adverse Event Reporting
Number of adverse events reported throughout entire study.
Measured: 24 weeks
Secondary outcomes (8)
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.).
Measured: 4 weeks after enrollment
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.
Measured: 4 weeks after enrollment
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.).
Measured: 10 weeks after stopping levodopa
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.
Measured: 10 weeks after stopping levodopa
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.
Measured: enrollment to 4 weeks
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.
Measured: enrollment to 4 weeks
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.
Measured: baseline to 10 weeks after stopping levodopa
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.
Measured: baseline to 10 weeks after stopping levodopa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmblyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Ray Kraker, Jaeb Center for Health Research
- Investigators
- Michael X. Repka, M.D., Study chair, Wilmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789672
- Sponsor's protocol ID
- NEI-141
- Other IDs
- 2U10EY011751
- Acronym
- ATS14
- Status last verified
- Jul 2016
- First submitted
- 27 Oct 2008
- Last updated
- 13 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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 for residual amblyopia in children aged 8 years to younger than 18 years. Arch Ophthalmol. 2010 Sep;128(9):1215-7. doi: 10.1001/archophthalmol.2010.178. No abstract available.
PubMed 20837811
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia in 8 to 17 Year Olds
- ClinicalTrials.gov ID
- NCT00789672
- Acronym / sponsor ID
- ATS14 / NEI-141
- Conditions
- Amblyopia
- Keywords
- Amblyopia, Patching, Levodopa
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 23 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Dose (3-1) levodopa/carbidopa | Active comparator | Device: patching, Drug: levodopa/carbidopaOral levodopa 0.51 mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication. |
| Higher Dose (4.5-1) levodopa/carbidopa | Active comparator | Drug: levodopa/carbidopa, Device: patchingOral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation) combined with 2 hours of daily patching, with a rapid taper of medication before a primary outcome exam 9 weeks after starting medication. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- Myopia more than -6.00 D (spherical equivalent) in either eye.
- Current vision therapy or orthoptics
- Ocular cause for reduced visual acuity
- Prior intraocular or refractive surgery
- History of narrow-angle glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| levodopa/carbidopaOral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid (approximately 4.5 to 1 formulation) | Drug | Higher Dose (4.5-1) levodopa/carbidopa |
| patchingAlso: Coverlet, 3M Opticlude, Ortopad®2 hours daily patching | Device | Higher Dose (4.5-1) levodopa/carbidopa, Lower Dose (3-1) levodopa/carbidopa |
| levodopa/carbidopaOral levodopa 0.51mg/kg tid with carbidopa 0.17 mg/kg tid (3 to 1 formulation) | Drug | Lower Dose (3-1) levodopa/carbidopa |
Primary outcome
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
Time frame: 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.).
Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
Time frame: 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.
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa
Time frame: baseline to 9 weeks
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.
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa
Time frame: baseline to 9 weeks
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.
Tolerability of Study Medication-Adverse Event Reporting
Time frame: 24 weeks
Number of adverse events reported throughout entire study.
8 secondary outcomes
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment
Time frame: 4 weeks after enrollment
Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment
Time frame: 4 weeks after enrollment
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
Time frame: 10 weeks after stopping levodopa
Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
Time frame: 10 weeks after stopping levodopa
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment
Time frame: enrollment to 4 weeks
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment
Time frame: enrollment to 4 weeks
Distribution of Change in Amblyopic Eye Visual Acuity Scores at 10 Weeks After Stopping Levodopa
Time frame: baseline to 10 weeks after stopping levodopa
Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa
Time frame: baseline to 10 weeks after stopping levodopa
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20837811Repka 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 for residual amblyopia in children aged 8 years to younger than 18 years. Arch Ophthalmol. 2010 Sep;128(9):1215-7. doi: 10.1001/archophthalmol.2010.178. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael X. Repka, M.D. study chair
Wilmer Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing levodopa/carbidopa and patching in people with Amblyopia, run by Jaeb Center for Health Research 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 6 inclusion and 21 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 13 Jul 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Yes. Results are posted in the registry (first posted 23 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa (time frame: 9 weeks after starting levodopa). The study lists 5 primary outcomes in all. 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 NCT00789672, 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 13 Jul 2016.