Trial · NCT00789672

Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia

NCT00789672, Phase 2, Completed, Jaeb Center for Health Research; results first posted 2011-03-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia. Trials, record NCT00789672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00789672

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pilot Study to Evaluate Levodopa as Treatment for Residual Amblyopia
NCT number: NCT00789672
Status: Completed
Phases: Phase 2
Enrollment: 33 participants, actual
Lead sponsor: Jaeb Center for Health Research
Conditions: Amblyopia
Interventions: levodopa/carbidopa, patching, levodopa/carbidopa
First posted: 2008-11-13
Last updated: 2016-07-13
Results first posted: 2011-03-23
Limitations and caveats: Without a patching-only control group, no conclusions can be made regarding efficacy, safety, or side effects with this treatment. Placebo controlled trial is needed to see if levodopa can augment occlusion therapy in the treatment of amblyopia.

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	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.).
Primary	Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	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.
Primary	Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa	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.
Primary	Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	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.
Primary	Tolerability of Study Medication-Adverse Event Reporting	24 weeks	Number of adverse events reported throughout entire study.
Secondary	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment	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.).
Secondary	Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment	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.
Secondary	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa	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.).
Secondary	Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa	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.
Secondary	Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment	enrollment to 4 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.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	9 weeks after starting levodopa	participants	NUMBER
PRIMARY	Mean Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	9 weeks after starting levodopa	letters	MEAN
PRIMARY	Distribution of Change in Amblyopic Eye Visual Acuity Scores at 9 Weeks After Starting Levodopa	baseline to 9 weeks	participants	NUMBER
SECONDARY	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks After Enrollment	4 weeks after enrollment	participants	NUMBER
SECONDARY	Mean Amblyopic Eye Visual Acuity Letter Scores at 4 Weeks Post Enrollment	4 weeks after enrollment	letters	MEAN
SECONDARY	Distribution of Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa	10 weeks after stopping levodopa	participants	NUMBER
SECONDARY	Mean Amblyopic Eye Visual Acuity Letter Scores at 10 Weeks After Stopping Levodopa	10 weeks after stopping levodopa	letters	MEAN
PRIMARY	Mean Change in Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	baseline to 9 weeks	letters	MEAN
PRIMARY	Tolerability of Study Medication-Adverse Event Reporting	24 weeks	events	NUMBER
SECONDARY	Distribution of Change in Amblyopic Eye Visual Acuity Scores at 4 Weeks Post Enrollment	enrollment to 4 weeks	participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group136

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Lower Dose 0.51 mg Levodopa/Carbidopa	<20/100 (<47 letters)	2	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Higher Dose 0.76 mg Levodopa/Carbidopa	<20/100 (<47 letters)	5	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Lower Dose 0.51 mg Levodopa/Carbidopa	20/100 (47 to 52 letters)	2	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Higher Dose 0.76 mg Levodopa/Carbidopa	20/100 (47 to 52 letters)	0	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Lower Dose 0.51 mg Levodopa/Carbidopa	20/80 (53 to 57)	1	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Higher Dose 0.76 mg Levodopa/Carbidopa	20/80 (53 to 57)	1	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Lower Dose 0.51 mg Levodopa/Carbidopa	20/63 (58 to 62)	3	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Higher Dose 0.76 mg Levodopa/Carbidopa	20/63 (58 to 62)	5	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Lower Dose 0.51 mg Levodopa/Carbidopa	20/50 (63 to 67)	4	participants
Distribution of Amblyopic Eye Visual Acuity Letter Scores at 9 Weeks After Starting Levodopa	Higher Dose 0.76 mg Levodopa/Carbidopa	20/50 (63 to 67)	3	participants

1 to 10 of 136Source ClinicalTrials.gov

See all 136 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Lower Dose 0.51 mg Levodopa/Carbidopa	16
Overall Study	STARTED	Higher Dose 0.76 mg Levodopa/Carbidopa	17
Overall Study	COMPLETED	Lower Dose 0.51 mg Levodopa/Carbidopa	16
Overall Study	COMPLETED	Higher Dose 0.76 mg Levodopa/Carbidopa	17
Overall Study	NOT COMPLETED	Lower Dose 0.51 mg Levodopa/Carbidopa	0
Overall Study	NOT COMPLETED	Higher Dose 0.76 mg Levodopa/Carbidopa	0

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	General disorders	Lower Dose 0.51 mg Levodopa/Carbidopa	3	16	6
other	Headache	General disorders	Higher Dose 0.76 mg Levodopa/Carbidopa	3	17	6
other	Cold/Upper Respiratory Infection/Cough	Respiratory, thoracic and mediastinal disorders	Lower Dose 0.51 mg Levodopa/Carbidopa	3	16	3
other	Cold/Upper Respiratory Infection/Cough	Respiratory, thoracic and mediastinal disorders	Higher Dose 0.76 mg Levodopa/Carbidopa	3	17	6
other	Rash	Skin and subcutaneous tissue disorders	Lower Dose 0.51 mg Levodopa/Carbidopa	1	16	1
other	Rash	Skin and subcutaneous tissue disorders	Higher Dose 0.76 mg Levodopa/Carbidopa	3	17	3
other	Flu	General disorders	Lower Dose 0.51 mg Levodopa/Carbidopa	2	16	2
other	Flu	General disorders	Higher Dose 0.76 mg Levodopa/Carbidopa	1	17	1
other	Nausea/Vomiting	Gastrointestinal disorders	Lower Dose 0.51 mg Levodopa/Carbidopa	2	16	2
other	Nausea/Vomiting	Gastrointestinal disorders	Higher Dose 0.76 mg Levodopa/Carbidopa	1	17	1

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Lower Dose 0.51 mg Levodopa/Carbidopa
Total, all-cause mortality	Higher Dose 0.76 mg Levodopa/Carbidopa
Total, other adverse events	Lower Dose 0.51 mg Levodopa/Carbidopa	8	16
Total, other adverse events	Higher Dose 0.76 mg Levodopa/Carbidopa	11	17
Total, serious adverse events	Lower Dose 0.51 mg Levodopa/Carbidopa	0	16
Total, serious adverse events	Higher Dose 0.76 mg Levodopa/Carbidopa	0	17

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20837811	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10EY011751	Pediatric Eye Disease Investigator Group Coordinating Center	KRAKER, RAYMOND	JAEB CENTER FOR HEALTH RESEARCH, INC.	NATIONAL EYE INSTITUTE	1997 to 2018

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Lower Dose 0.51 mg Levodopa/Carbidopa vs Higher Dose 0.76 mg Levodopa/Carbidopa: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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