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The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).
The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.
Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.
The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I- All | Experimental | Subjects with neovascular AMD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AM712(ASKG712) | Biological | AM712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of ocular adverse events (AEs) of the study eyes | To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD) | 252 days |
| Incidence of non-ocular AEs | To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD) | 252 days |
| Any relevant safety observations derived from BCVA | To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD) | 252 days |
| Any relevant safety observations derived from SD-OCT | To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD) | 252 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in central subfield thickness as assessed by SD-OCT | To evaluate the efficacy of AM712 in Subjects with nAMD | 252 days |
| Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT |
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Inclusion Criteria:
Exclusion Criteria:
ALT or AST > 2 x ULN, total bilirubin > 1.5 x ULN Serum creatinine > 1.5 x ULN, BUN > 2 x ULN HbA1c > 7.5% at screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants San Diego | Poway | California | 92064 | United States | ||
| Bay Area Retina Associates |
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The Phase 1 study is comprised of open-label multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).
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To evaluate the efficacy of AM712 in Subjects with nAMD |
| 252 days |
| Mean change from baseline in BCVA (ETDRS) | To evaluate the efficacy of AM712 in Subjects with nAMD | 252 days |
| Proportion of patients gaining ≥ 15 letters from baseline BCVA | To evaluate the efficacy of AM712 in Subjects with nAMD | 252 days |
| Walnut Creek |
| California |
| 94598 |
| United States |
| Colorado Retina | Lakewood | Colorado | 80228 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Retina Research Institute at New England Retina Consultants | Springfield | Massachusetts | 01107 | United States |
| Tennessee Retina, PC | Nashville | Tennessee | 37203 | United States |
| Retina Consultants of Texas | Bellaire | Texas | 77401 | United States |
| Retina Consultants of Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Texas | The Woodlands | Texas | 77384 | United States |