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| Name | Class |
|---|---|
| Snyder Biomedical Corporation | OTHER |
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This protocol is an extension of protocol 0002, Proof of Concept and Dose Ranging Study of carbidopa-levodopa in Neovascular AMD. that is a 3 month study of escalating doses of carbidopa-levodopa in neovascular AMD. This trial is a 9 month extension for patients who successfully complete protocol 0002 and wish to continue carbidopa-levodopa therapy. It will use the two higher dose regimens of protocol 0002. these will be assigned according to how well the higher dose was tolerated in protocol 0002.
This extension will employ the same medications, measurements, guidelines for anti-VEGF injections and safeguards as in protocol 0002. In combination with protocol 0002, it will provide a total of 12 months of therapy with carbidopa-levodopa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbidopa/levodopa high dose | Experimental | carbidopa-levodopa 25-100 mg 2 tablets TID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carbidopa-levodopa 25-100 mg | Drug | High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events Experienced | Adverse events elicited by nonspecific questioning | Monthly for 9 months |
| Change in Central Retinal (Macular) Thickness | 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. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert W Snyder, MD, PhD | Robert W Snyder | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert W Snyder, MD, PhD, PC | Tucson | Arizona | 85712 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Intermediate Dose: daily oral administration 1 tablet TID |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Best Corrected Visual Acuity by ETDRS Visual Scale Testing | 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. | 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. | Posted | Mean | Standard Error | Change in letters (BCVA) | 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. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain due to torn chest muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
The major limitations of our study include the small sample size and limited patient racial diversity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert W. Snyder | Robert W Snyder, MD, PhD, PC | 5206616516 | rsnyder781@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 24, 2017 | Sep 8, 2025 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
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Patients who complete 3 months of escalation dose carbidopa-levodopa, will receive 9 additional months of therapy with the highest dose used in protocol 0002, carbidopa-levodopa 25-100 mg 2 tablets TID.
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|
| 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. |
| Percent Change in Retinal Fluid From Baseline | 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. | 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. |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patients naive to anti-VEGF injections at start of study | Count of Participants | Participants |
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| Secondary | Number of Adverse Events Experienced | Adverse events elicited by nonspecific questioning | 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. | Posted | Count of Participants | Participants | Monthly for 9 months |
|
|
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| Secondary | Change in Central Retinal (Macular) Thickness | 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. | 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. | Posted | Mean | Standard Error | microns | 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. |
|
|
|
| Secondary | Percent Change in Retinal Fluid From Baseline | 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. | 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. | Posted | Mean | Standard Error | percent change | 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. |
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| 0 |
| 30 |
| 0 |
| 30 |
| 3 |
| 30 |
| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Malaise | Gastrointestinal disorders | Systematic Assessment |
|
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