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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023900-29 | EudraCT Number |
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This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozurdex® | Active Comparator | Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter. |
|
| Lucentis® | Active Comparator | Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant | Drug | Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Best Corrected Visual Acuity (BCVA) | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement. | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | 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 12. A negative change from Baseline indicates improvement. | Baseline, Month 12 |
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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 |
|---|---|---|---|---|---|---|
| Paris | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29631435 | Background | Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ozurdex® | Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter. |
| FG001 | Lucentis® | Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ozurdex® | Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter. |
| BG001 | Lucentis® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Best Corrected Visual Acuity (BCVA) | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement. | Participants from the intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Mean | Standard Deviation | letters | Baseline, Month 12 |
|
Up to 60 Weeks
Safety population, all randomized participants who received at least 1 dose of study drug, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.
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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 | Ozurdex® | Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allergan Inc., | Allergan, Inc | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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|
| ranibizumab | Biological | Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria. |
|
|
| Percentage of Patients With 15-or-More Letter Improvement in BCVA | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved. | Baseline, Month 12 |
| Percentage of Patients With a 15-or-More Letter Decrease in BCVA | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). | Baseline, Month 12 |
| Time to BCVA Improvement of 15-or-More Letters | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters. | 12 Months |
| Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement. | Baseline, Month 12 |
| Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure | Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy. | 12 Months |
| Munich |
| Germany |
| Tel Aviv | Israel |
| Milan | Italy |
| Madrid | Spain |
| London | United Kingdom |
| Lost to Follow-up |
|
| Withdrawal of consent |
|
| Protocol Violation |
|
| Death |
|
| Other miscellaneous reasons |
|
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Lucentis® | Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria. |
|
|
| Secondary | Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) | 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 12. A negative change from Baseline indicates improvement. | Participants from the intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Mean | Standard Deviation | microns | Baseline, Month 12 |
|
|
|
| Secondary | Percentage of Patients With 15-or-More Letter Improvement in BCVA | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved. | Participants from the intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Number | percentage of participants | Baseline, Month 12 |
|
|
|
| Secondary | Percentage of Patients With a 15-or-More Letter Decrease in BCVA | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). | Participants from the intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Number | percentage of participants | Baseline, Month 12 |
|
|
|
| Secondary | Time to BCVA Improvement of 15-or-More Letters | BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters. | Participants from the intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Mean | Standard Deviation | days | 12 Months |
|
|
|
| Secondary | Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) | The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement. | Participants from the intent-to-treat population, all randomized participants, with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Month 12 |
|
|
|
| Secondary | Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure | Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy. | Intent-to-treat population included all randomized participants. | Posted | Number | percentage of participants | 12 Months |
|
|
|
| 12 |
| 153 |
| 127 |
| 153 |
| EG001 | Lucentis® | Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria. | 16 | 150 | 104 | 150 |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bradyarrhythmia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myocardial ischaemia | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Agitated depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Lenticular opacities | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| 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 |