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The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.
Following a single administration, patients will be followed for 6 months postinjection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL-39324 Concentration Level A | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection |
|
| AL-39324 Concentration Level B | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection |
|
| AL-39324 Concentration Level C | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection |
|
| AL-39324 Concentration Level D | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection |
|
| AL-39324 Concentration Level E | Experimental | AL-39324 ophthalmic suspension, single intravitreal injection |
|
| Lucentis | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AL-39324 ophthalmic suspension | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of targeted adverse events occurring in the study eye | Up to Day 7 after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in central foveal thickness (CFT) at Month 1 | Baseline (Day 0), Month 1 |
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Inclusion Criteria:
Willing to give written informed consent, make the required study visits and follow instructions;
The study eye:
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M. Kissner, Ph.D. | Alcon Research | Study Director |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Ranibizumab 10 mg/mL solution, single intravitreal injection |
|
| Ranibizumab 10 mg/mL | Drug |
|
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |