Trial Outcomes & Findings for Extension, Carbidopa-levodopa in Neovascular Age-related Macular Degeneration (AMD) (NCT NCT03197493)

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059.

Results posted on

2025-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	Carbidopa/Levodopa High Dose carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID
Overall Study STARTED	35
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Carbidopa/Levodopa High Dose carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID
Overall Study Withdrawal by Subject	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carbidopa/Levodopa High Dose n=30 Participants carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=30 Participants
Age, Categorical >=65 years	28 Participants n=30 Participants
Age, Continuous	75 years n=30 Participants
Sex: Female, Male Female	16 Participants n=30 Participants
Sex: Female, Male Male	14 Participants n=30 Participants
Region of Enrollment United States	30 participants n=30 Participants
Patients naive to anti-VEGF injections at start of study	15 Participants n=30 Participants

PRIMARY outcome

Timeframe: From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059.

Population: This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.

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

Outcome measures
Measure	High Dose n=30 Participants carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing	2.7 Change in letters (BCVA) Standard Error 1.8

SECONDARY outcome

Timeframe: Monthly for 9 months

Population: This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.

Adverse events elicited by nonspecific questioning

Outcome measures

Outcome measures
Measure	High Dose n=30 Participants carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
Number of Adverse Events Experienced	3 Participants

SECONDARY outcome

Timeframe: From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, a maximum of 9 months.

Population: This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.

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

Outcome measures
Measure	High Dose n=30 Participants carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
Change in Central Retinal (Macular) Thickness	-18.0 microns Standard Error 17.5

SECONDARY outcome

Timeframe: From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study, (visit 10), a maximum of 9 months.

Population: This population includes participants who completed NCT03022318 (naive to anti-VEGF injections at the time of enrollment) and patients who did not complete NCT03022318 but had been exposed to anti-VEGF injections before study initiation.

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

Outcome measures
Measure	High Dose n=30 Participants carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
Percent Change in Retinal Fluid From Baseline	-3.8 percent change Standard Error 24.8

Adverse Events

High Dose

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	High Dose n=30 participants at risk carbidopa-levodopa 25-100 mg 2 tablets TID carbidopa-levodopa 25-100 mg: High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
Musculoskeletal and connective tissue disorders Chest pain due to torn chest muscle	3.3% 1/30 • From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059. A total of 9 months.
Nervous system disorders Lightheadedness	3.3% 1/30 • From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059. A total of 9 months.
Gastrointestinal disorders Malaise	3.3% 1/30 • From the start of the study (Visit 1) to the last completed visit, whether due to patient withdrawal, patient death or the completion of the last visit of the study (visit 12), a maximum of 9 months following a 3 month enrollment in NCT03023059. A total of 9 months.

Additional Information

Dr. Robert W. Snyder

Robert W Snyder, MD, PhD, PC

Phone: 5206616516

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place