Trial Outcomes & Findings for Carbidopa-levodopa in Neovascular AMD (NCT NCT03022318)
NCT ID: NCT03022318
Last Updated: 2025-09-12
Results Overview
This outcome is a measure of letters correctly identified using an Early Treatment Diabetic Retinopathy Study chart. The higher the number of letters identified, the better the participant's visual acuity.
COMPLETED
PHASE2
20 participants
From start of study to first anti-vascular endothelial growth factor (VEGF) injection (8-32 days)
2025-09-12
Participant Flow
Participant milestones
| Measure |
Once Daily
carbidopa-levodopa 25-100 mg tablets once daily hs for up to 32 days
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
3 Times Daily
carbidopa-levodopa 25-100 mg tablets 3 times daily,in the morning, with supper and hs for up to 32 days
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Once Daily
n=10 Participants
carbidopa-levodopa 25-100 mg tablets once daily hs for up to 32 days in patients naive to anti-vascular endothelial growth factor (VEGF) injections
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
3 Times Daily
n=7 Participants
carbidopa-levodopa 25-100 mg tablets 3 times daily,in the morning, with supper and hs for up to 32 days in patients naive to anti-VEGF injections
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=10 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=10 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=17 Participants
|
|
Age, Continuous
|
76.4 years
n=10 Participants
|
74.1 years
n=7 Participants
|
75.5 years
n=17 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=17 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 Participants
n=10 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=17 Participants
|
|
Patients naive to anti-VEGF injections at start of study
|
10 Participants
n=10 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=17 Participants
|
PRIMARY outcome
Timeframe: From start of study to first anti-vascular endothelial growth factor (VEGF) injection (8-32 days)Population: Statistical comparisons between these two dosages were not completed given the design of this exploratory study. Our publication published findings based on overall exposure to levodopa but did take into account potential adverse effects associated with higher dose frequency of levodopa.
This outcome is a measure of letters correctly identified using an Early Treatment Diabetic Retinopathy Study chart. The higher the number of letters identified, the better the participant's visual acuity.
Outcome measures
| Measure |
Carbidopa/Levodopa Once Daily
n=10 Participants
carbidopa-levodopa 25-100 mg tablets once daily at bedtime for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
Carbidopa/Levodopa Three Times Daily
n=7 Participants
carbidopa-levodopa three times daily for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
|---|---|---|
|
Change in Best Corrected Visual Acuity
|
6.0 Change in letters (BCVA)
Standard Error 1.9
|
4.6 Change in letters (BCVA)
Standard Error 1.6
|
SECONDARY outcome
Timeframe: From start of study to first anti-VEGF injection (8-32 days).Population: Statistical comparisons between these two dosages were not completed given the design of this exploratory study. Our publication published findings based on overall exposure to levodopa but did take into account potential adverse effects associated with higher dose frequency of levodopa.
Central retinal thickness (in microns) is measured by spectral domain-optical coherence tomography. An increase in retinal thickness is associated with disease progression. A negative value represents a decrease in retinal thickness and therefore a positive clinical outcome measure.
Outcome measures
| Measure |
Carbidopa/Levodopa Once Daily
n=10 Participants
carbidopa-levodopa 25-100 mg tablets once daily at bedtime for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
Carbidopa/Levodopa Three Times Daily
n=7 Participants
carbidopa-levodopa three times daily for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
|---|---|---|
|
Change in Central Retinal (Macular) Thickness
|
-26.3 microns
Standard Error 13.4
|
-10.3 microns
Standard Error 10.9
|
SECONDARY outcome
Timeframe: From start of study to first anti-VEGF injection (8-32 days)Retinal fluid changes on direct retinal examination on spectral domain - optical coherence tomography. Changes in retinal fluid were compared to baseline values. A negative percentage point represents a decrease in retinal fluid and therefore a positive clinical outcome.
Outcome measures
| Measure |
Carbidopa/Levodopa Once Daily
n=10 Participants
carbidopa-levodopa 25-100 mg tablets once daily at bedtime for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
Carbidopa/Levodopa Three Times Daily
n=7 Participants
carbidopa-levodopa three times daily for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
|---|---|---|
|
Percent Change in Retinal Fluid From Baseline
|
-26.4 percent change
Standard Error 11.7
|
-32.4 percent change
Standard Error 13.5
|
SECONDARY outcome
Timeframe: From start of study to first anti-VEGF injection (8-32 days)Population: Statistical comparisons between these two dosages were not completed given the design of this exploratory study. Our publication published findings based on overall exposure to levodopa but did take into account potential adverse effects associated with higher dose frequency of levodopa.
Vital signs, eye examinations and nondirected subjective adverse events
Outcome measures
| Measure |
Carbidopa/Levodopa Once Daily
n=10 Participants
carbidopa-levodopa 25-100 mg tablets once daily at bedtime for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
Carbidopa/Levodopa Three Times Daily
n=7 Participants
carbidopa-levodopa three times daily for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
|---|---|---|
|
Treatment Emergent Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Carbidopa/Levodopa Once Daily
Carbidopa/Levodopa Three Times Daily
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carbidopa/Levodopa Once Daily
n=10 participants at risk
carbidopa-levodopa 25-100 mg tablets once daily hs for up to 32 days in patients naive to anti-VEGF injections.
carbidopa-levodopa 25-100 mg tablets: See arm/group descriptions
|
Carbidopa/Levodopa Three Times Daily
n=7 participants at risk
carbidopa-levodopa 25-100 mg tablets three times daily for up to 32 days in patients naive to anti-VEGF injections.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear issues
|
10.0%
1/10 • Number of events 1 • 1 month
Adverse event reporting was based on participant-reported systemic adverse events during each study visit. The goal of evaluating differences in once daily and three times daily dosing was to evaluate potential differences in the tolerance/safety of both arms. This is the only secondary outcome that evaluated total daily dose differences of carbidopa/levodopa.
|
0.00%
0/7 • 1 month
Adverse event reporting was based on participant-reported systemic adverse events during each study visit. The goal of evaluating differences in once daily and three times daily dosing was to evaluate potential differences in the tolerance/safety of both arms. This is the only secondary outcome that evaluated total daily dose differences of carbidopa/levodopa.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place