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The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 700 µg dexamethasone and ranibizumab | Experimental | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Baseline, Week 26 |
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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 |
|---|---|---|---|---|---|---|
| San Antonio | Texas | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 700 µg Dexamethasone + Ranibizumab | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ranibizumab | Biological | Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye. |
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| Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%). | Baseline, Week 26 |
| Sydney |
| New South Wales |
| Australia |
| Manila | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 700 µg Dexamethasone + Ranibizumab | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | 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 | Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4 | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4. | Participants from the Intent to treat Population consisting of all enrolled participants with data available at Week 4 for analyses. | Posted | Mean | Standard Deviation | Microns | Baseline, Week 4 |
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| Secondary | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. | Intent to treat population consisting of all enrolled participants. | Posted | Mean | Standard Deviation | Number of letters | Baseline, Week 26 |
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| Secondary | Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26 | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA at Week 26 was compared to FA at Baseline. The percentage of participants in each of the following categories is reported: Improved (Leakage area decreased >=10%), Unchanged (Leakage area changed < 10%) and Worsened (Leakage area increased >=10%). | Participants from the Intent to treat population consisting of all enrolled participants with data available for analysis at Week 26. | Posted | Number | Percentage of participants | Baseline, Week 26 |
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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 | 700 µg Dexamethasone + Ranibizumab | 700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion. | 6 | 44 | 9 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v. 13.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v. 13.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA v. 13.0 | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA v. 13.0 | Systematic Assessment | Event not related to study drug or study procedure |
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| Fall | Injury, poisoning and procedural complications | MedDRA v. 13.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v. 13.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v. 13.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v. 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA v. 13.0 | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA v. 13.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 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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