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The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexamethasone and ranibizumab | Experimental | Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. |
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| sham and ranibizumab | Sham Comparator | Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone | Drug | Intravitreal injection of dexamethasone 700 µg at Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Injection Free Interval | The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye. | Week 1 to Week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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. |
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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 |
|---|---|---|---|---|---|---|
| Boynton Beach | Florida | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26088793 | Background | Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex(R) ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone and Ranibizumab | Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. |
| FG001 | Sham and Ranibizumab | Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| ranibizumab | Biological | Ranibizumab 500 µg at day -30 and Day 7-14. |
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| sham | Other | Sham needle-less injection administered in the study eye at Day 1. |
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| Baseline, Week 25 |
| Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25. | Baseline, Week 25 |
| Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye | 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 was performed on the study eye after dilation at Screening and Week 25. | Screening (-Week 28), Week 25 |
| Parramatta |
| New South Wales |
| Australia |
| Paris | France |
| Tel Aviv | Israel |
| Milan | Italy |
| Auckland | New Zealand |
| Coimbra | Portugal |
| Seoul | South Korea |
| Southampton | Hampshire | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone and Ranibizumab | Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. |
| BG001 | Sham and Ranibizumab | Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Injection Free Interval | The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye. | Intent-to-treat population consisted of all randomized patients. | Posted | Median | Inter-Quartile Range | Days | Week 1 to Week 25 |
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| Secondary | Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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. | Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses. | Posted | Mean | Standard Deviation | Letters | Baseline, Week 25 |
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| Secondary | Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and Month 25. | Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses. | Posted | Mean | Standard Deviation | Microns | Baseline, Week 25 |
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| Secondary | Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye | 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 was performed on the study eye after dilation at Screening and Week 25. | Participants from the intent-to-treat population (all randomized participants) with data available at Screening and Week 25 for analyses. | Posted | Mean | Standard Deviation | Millimeters square (MM^2) | Screening (-Week 28), Week 25 |
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Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized participants who received study drug.
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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 | Dexamethasone and Ranibizumab | Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14. | 9 | 121 | 86 | 121 | ||
| EG001 | Sham and Ranibizumab | Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14. | 14 | 118 | 59 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Renal failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Therapeutic agent toxicity | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment | verbatim term= digoxin toxicity |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Stupor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Enterococcal infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Hernia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Mitral valve incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Escherichia bacteraemia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
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| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Intraocular pressure increased | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Macular degeneration | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Vitreous floaters | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Cataract subcapsular | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 10.0 | Systematic Assessment |
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| Vitreous detachment | Eye disorders | MedDRA 10.0 | 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 |
| C005703 | salicylhydroxamic acid |
| 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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| Male |
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