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| Name | Class |
|---|---|
| The Macula Foundation, Inc. | OTHER |
| Genentech, Inc. | INDUSTRY |
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This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO & CRUISE trials and subsequently followed in the HORIZON extension trial.
There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab as needed | Experimental | Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Serious Adverse Events. | Record the serious adverse events, both ocular and non-ocular to gather long-term safety data. | 24 mos |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Changes in Visual Acuity | Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision. | 24 mos from study baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter A Campochiaro, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Retinal Consultants Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20630595 | Background | Campochiaro PA, Hafiz G, Channa R, Shah SM, Nguyen QD, Ying H, Do DV, Zimmer-Galler I, Solomon SD, Sung JU, Syed B. Antagonism of vascular endothelial growth factor for macular edema caused by retinal vein occlusions: two-year outcomes. Ophthalmology. 2010 Dec;117(12):2387-2394.e1-5. doi: 10.1016/j.ophtha.2010.03.060. Epub 2010 Jul 13. | |
| 20398941 |
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66 retinal vein occlusion patients from the HORIZON study(NCT01198327)were enrolled from 7 sites for long term follow up. The sites were: Wilmer Eye Institute, Ophthalmic Consultants of Boston, Retina Consultants of New Jersey, Retina Consultants Macula Group,Retina Consultants of Houston, Southeast Retina and Retina Vitreous Associates
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab as Needed | Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab as Needed | Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Incidence of Serious Adverse Events. | Record the serious adverse events, both ocular and non-ocular to gather long-term safety data. | Posted | Number | number of serious adverse events | 24 mos |
|
|
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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 | Ranibizumab as Needed | Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death resulting from pre-existing idiopathic pulmonary fibrosis | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | General disorders | This adverse event was specified as "Upper respiratory Infection". It was reported if a study subject had a common cold, viral bronchitis or sinusitis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Campocahiro | Wilmer Eye Institute | 410-955-5106 | pcampo@jhmi.edu |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C002205 | zorubicin |
| D007834 | Lasers |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Peripheral Laser | Other | Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections. |
|
|
| Mean Change in Retinal Thickness | Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography). | 24 mos from study baseline |
| Sacremento |
| California |
| 95819 |
| United States |
| Southeast Retina | Augusta | Georgia | 30909 | United States |
| Ophthalmic consultants of Boston | Boston | Massachusetts | 02114-2587 | United States |
| Retina Associates of New Jersey | Teaneck | New Jersey | 07666 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Mean Changes in Visual Acuity | Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision. | Posted | Mean | Standard Deviation | ETDRS letters | 24 mos from study baseline |
|
|
|
| Secondary | Mean Change in Retinal Thickness | Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography). | Posted | Mean | Standard Deviation | microns | 24 mos from study baseline |
|
|
|
| 17 |
| 66 |
| 53 |
| 66 |
| Death of unknown cause | General disorders | Reason for death could not be found out, despite multiple attempts to contact family members. |
|
| ECG for elective knee surgery showed inverted T waves, patient asymptomatic, admitted for workup | Cardiac disorders | Coronary artery bypass surgery, recovered |
|
| Mild chest discomfort for 6 mos, coronary angiography showed 2 obstructions | Cardiac disorders | Elective placement of 2 stents without complications, recovered |
|
| Tachycardia and went to the emergency department | Cardiac disorders | Cardioverter defibrillator implanted, recovered |
|
| Syncope with fall because of arrhythmia | Cardiac disorders | Pacemaker implanted, recovered |
|
| Chronic atrial fibrillation, CVA; bladder cancer identified during hospitalization | General disorders | Pacemaker implanted, administered anticoagulants,underwent surgery for bladder cancer; recovered |
|
| Head injury resulting from fall | General disorders | Received staples for scalp laceration, recovered |
|
| Urinary tract infection leading to septic shock | Infections and infestations | Hospitalized, recovered |
|
| Hospitalized for pneumonia | Infections and infestations | Recovered |
|
| Hospitalized for elective surgery | Musculoskeletal and connective tissue disorders | Recovered |
|
| Vitreous hemorrhage, | Eye disorders | resolved spontaneously |
|
| Second branch retinal vein occlusion in same eye | Eye disorders | Patient with an inferior branch retinal vein occlusion had resolution of edema, but a superior branch vein occlusion developed 27 months after last ranibizumab injection. Had severe ischemia, and neovascular glaucoma developed. |
|
| Retinal tear in a patient with branch retinal vein occlusion who did not receive any treatment | Eye disorders |
|
| Severe reaction to povidon-iodine | Eye disorders |
|
|
| Ocular discomfort | Eye disorders | Discomfort after intravitreal injection |
|
| Subconjuctival Hemorrhage | Eye disorders |
|
| Vitreous Hemmorhage | Eye disorders |
|
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| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |