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| ID | Type | Description | Link |
|---|---|---|---|
| PALM | Other Identifier | Allergan |
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This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| abicipar pegol 2 mg (group A) | Experimental | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24. |
|
| abicipar pegol 2 mg (group B) | Experimental | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. |
|
| abicipar pegol 1 mg | Experimental | Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. |
|
| ranibizumab | Active Comparator | Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| abicipar pegol | Drug | Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Best Corrected Visual Acuity (BCVA) | Baseline, Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale | Baseline, 28 Weeks | |
| Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye | Baseline, Week 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gilbert | Arizona | United States | ||||
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| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000630582 | abicipar pegol |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| ranibizumab | Drug | Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. |
|
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| sham procedure | Other | Sham procedure to the study eye at the visits noted per protocol. |
|
| Percentage of Patients with a BCVA of ≥70 Letters | 28 Weeks |
| Percentage of Patients with Resolution of Macular Edema | 28 Weeks |
| Abilene |
| Texas |
| United States |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |