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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.
The secondary objectives are to assess the efficacy of 0.5mg versus 2.0mg of monthly ranibizumab injections in patients with macular edema due to retinal vein occlusion between baseline and month 6. At week 24, patients will be re-randomized to receive pro re nata (prn) ranibizumab+laser photocoagulation versus ranibizumab alone and the efficacy of both treatment options will be compared. Treatment efficacy will be assessed by comparing changes in best corrected visual acuity (BCVA) and central subfiled thickness (CST) between the treatment groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRVO- Ranibizumab 0.5mg alone | Experimental | Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation. |
|
| BRVO- Pro re nata (prn) ranibizumab with laser | Experimental | Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required. |
|
| BRVO- Ranibizumab 2.0mg alone | Experimental | Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation. |
|
| BRVO- Pro re nata (prn) ranibizumab | Experimental | Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation. |
|
| CRVO- Ranibizumab 0.5mg alone | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5mg (monthly) | Drug | Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Ocular and Non-ocular Adverse Events. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Baseline to month 6 | |
| Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. |
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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 |
|---|---|---|---|---|---|---|
| Wilmer Eye Institute at Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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Eighty-one patients with retinal vein occlusion were enrolled at a single center (The Wilmer Eye Institute, Johns Hopkins Hospital, Baltimore,MD).
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| ID | Title | Description |
|---|---|---|
| FG000 | BRVO- Ranibizumab 0.5mg Alone | Branch retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg of ranibizumab alone for 6 months. |
| FG001 | BRVO- Ranibizumab 2.0mg Alone | Branch retinal vein occlusion patients randomized to this group at baseline will receive 2.0mg of Ranibizumab alone for 6 months. |
| FG002 | BRVO- Pro re Nata (Prn) Ranibizumab Alone | Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata 0.5mg/2.0mg of ranibizumab without laser photocoagulation. |
| FG003 | BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation | Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) ranibizumab along with laser photocoagulation. |
| FG004 | CRVO- Ranibizumab 0.5mg Alone | Central retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg at of ranibizumab alone for 6 months. |
| FG005 | CRVO- Ranibizumab 2.0mg Alone | Central retinal vein occlusion patients randomized to this group at baseline will receive ranibizumab 2.0mg alone for 6 months . |
| FG006 | CRVO- Pro re Nata (Prn) Ranibizumab Alone | Central retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation. |
| FG007 | CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation | Central retinal vein occlusion patients randomized to this group at month 6 will receive 0.5mg/2.0mg prn ranibizumab along with laser photocoagulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Month 6 |
| |||||||||||||
| Month 6-Month 36 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BRVO- Ranibizumab 0.5mg Alone | Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation. BRVO -Ranibizumab 0.5mg alone: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone |
| BG001 |
| 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 | Incidence and Severity of Ocular and Non-ocular Adverse Events. | Posted | Number | participants | 36 months |
|
|
From Baseline to Month 36
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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 | BRVO | Patients with Branch Retinal Vein Occlusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection Requiring Hospitalization | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased IOP | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter A. Campochiaro, MD | Wilmer Eye Institute, Johns Hopkins University School of Medicine | (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 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
|
| CRVO- Pro re nata (prn) ranibizumab with laser | Experimental | Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required. |
|
| CRVO- Ranibizumab 2.0mg alone | Experimental | Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation. |
|
| CRVO- Pro re nata (prn) ranibizumab | Experimental | Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation. |
|
| Ranibizumab 2.0mg (monthly) | Drug |
|
| Pro re nata (prn) ranibizumab | Drug |
|
| Pro re nata (prn) Laser photocoagulation | Procedure |
|
| Month 6- Month 36 |
| Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Baseline to month 6 |
| Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | Month 6- Month 36 |
| COMPLETED |
|
| NOT COMPLETED |
|
| BRVO- Ranibizumab 2.0mg Alone |
Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation. BRVO- Ranibizumab 2.0 mg alone: Branch retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone |
| BG002 | CRVO- Ranibizumab 0.5mg Alone | Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation CRVO -Ranibizumab 0.5mg alone: Central retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone |
| BG003 | CRVO- Ranibizumab 2.0mg Alone | Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation. CRVO- Ranibizumab 2.0 mg alone: Central retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Posted | Mean | Standard Error | Letters | Baseline to month 6 |
|
|
|
| Secondary | Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | Posted | Mean | Standard Error | Letters | Month 6- Month 36 |
|
|
|
| Secondary | Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab | Posted | Mean | Standard Error | microns | Baseline to month 6 |
|
|
|
| Secondary | Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone. | Posted | Mean | Standard Error | microns | Month 6- Month 36 |
|
|
|
| 17 |
| 42 |
| 37 |
| 42 |
| EG001 | CRVO | Patients with Central Retinal Vein Occlusion | 12 | 39 | 35 | 39 |
| Worsening of Cataract/Cataract Surgery | Eye disorders | Systematic Assessment |
|
| Hospitalization for Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Vertebral Fracture/Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Cerebrovascular event | Nervous system disorders | Systematic Assessment |
|
| Hospitalization for Septic Shock | Infections and infestations | Systematic Assessment |
|
| Knee surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Vitreous Hemorrhage resulting in significant visual loss | Eye disorders | Systematic Assessment |
|
| Severe Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Kidney Surgery | Renal and urinary disorders | Systematic Assessment |
|
| Trabulectomy | Eye disorders | Systematic Assessment |
|
| Severe Cheat pain/Acute Coronary Syndrome | Cardiac disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Colon Surgery | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization due to multiple systemic diseases | General disorders | Systematic Assessment |
|
| Brain Surgery | Nervous system disorders | Systematic Assessment |
|
| Transient global Amnesia | Nervous system disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Serious Drug Allergy requiring Hospitalization | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypertensive Crisis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Surgery for Macular Pucker | Eye disorders | Systematic Assessment |
|
| Hospitalization for Thyroiditis | Endocrine disorders | Systematic Assessment |
|
| Parotid Gland Swelling | Endocrine disorders | Systematic Assessment |
|
| Pancreatic Mass | Gastrointestinal disorders | Systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Tooth Extraction | General disorders | Systematic Assessment |
|
| Skin Lesion/Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Common Cold/cough | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Sinusitis | General disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Worsening Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hernia Repair Surgery | Gastrointestinal disorders | Systematic Assessment |
|
| Fall | General disorders | Systematic Assessment |
|
| Back Pain | General disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Blurry vision | Eye disorders | Systematic Assessment |
|
| Vitreous Hemorrhage | Eye disorders | Systematic Assessment |
|
| Squamous Cell/Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Worsening Hypercholesterlemia | General disorders | Systematic Assessment |
|
| Foot Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Seasonal Allergy | General disorders | Systematic Assessment |
|
| Gout | General disorders | Systematic Assessment |
|
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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 |