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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.
This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.
Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab | Active Comparator | ranibizumab 0.5mg in commercially available vial |
|
| ranibizumab pre filled-syringe | Experimental | ranibizumab 0.5mg in soon to be available pre-filled syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab Injection [Lucentis] | Drug | intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure is mean change in ETDRS BCVA visual acuity | The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of eyes that gain or lose >0 letters at 24 weeks | Proportion of eyes that gain or lose >0 letters at 24 weeks | 24 weeks |
| Proportion of eyes that gain or lose > 5 letters at 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charlotte Eye Ear Nose and Throat Associates, PA | Charlotte | North Carolina | 28210 | United States | ||
| Charlotte Eye Ear Nose and Throat Associates, PA |
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Proportion of eyes that gain or lose > 5 letters at 24 weeks
| 24 weeks |
| Proportion of eyes that gain or lose > 10 letters at 24 weeks | Proportion of eyes that gain or lose > 10 letters at 24 weeks | 24 weeks |
| Proportion of eyes that gain or lose > 15 letters at 24 weeks | Proportion of eyes that gain or lose > 15 letters at 24 weeks | 24 weeks |
| To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting | To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting | 24 weeks |
| • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks | • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks | 24 weeks |
| Statesville |
| North Carolina |
| 28677 |
| United States |
| 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 |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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