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Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.0mg of ALG-1001 | Experimental | 2.0mg of ALG-1001 |
|
| Intravitreal injection in 0.05cc balanced salt solution. | Placebo Comparator | Balanced Salt Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.0mg of ALG-1001 | Drug |
| ||
| Balanced Salt Solution |
| Measure | Description | Time Frame |
|---|---|---|
| Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) | The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT. | 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| California Retina Consultants |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2.0mg of ALG-1001 | 2.0mg of ALG-1001 2.0mg of ALG-1001 |
| FG001 | Intravitreal Injection in 0.05cc BSS | Balanced Salt Solution Balanced Salt Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Santa Barbara |
| California |
| 93103 |
| United States |
| Center for Retinal and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Retina Consultants Houston | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 2.0mg of ALG-1001 | 2.0mg of ALG-1001 2.0mg of ALG-1001 |
| BG001 | Intravitreal Injection in 0.05cc BSS | Balanced Salt Solution Balanced Salt Solution |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) | The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT. | Posted | Count of Participants | Participants | 90 Days |
|
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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 | 2.0mg of ALG-1001 | 2.0mg of ALG-1001 2.0mg of ALG-1001 | 0 | 23 | 0 | 23 | 0 | 23 |
| EG001 | Intravitreal Injection in 0.05cc BSS | Balanced Salt Solution Balanced Salt Solution | 0 | 22 | 0 | 22 | 0 | 22 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Allegro Ophthalmics, LLC | 949-444-5722 | lkarageozian@allegroeye.com |
| ID | Term |
|---|---|
| C000712274 | risuteganib |
| C072670 | Hanks Balanced Salt Solution |
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| >=65 years |
|
| Male |
|