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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Uveitic Cystoid Macular Edema (CME) is a major cause of visual loss associated with uveitis. Systemic and/or local corticosteroid therapy and systemic immunosuppression with steroid-sparing agents such as cyclosporine, methotrexate, azathioprine, or others, effectively treats uveitis and associated CME in many patients. However, in many cases, CME persists in spite of adequate suppression of uveitis. No consensus exists on how best to treat such cases. The further addition of immunosuppressive agents appears to have little effect on this form of CME. Oral corticosteroids are useful, but high dosage and prolonged use can be associated with serious side-effects. Periocular and intravitreal corticosteroid injections are associated with well-known, significant side effects such as glaucoma and cataract formation.
Vascular endothelial growth factor (VEGF) is suspected to play a role in the loss of vascular integrity in the eye and known to be induced by inflammatory cytokines, such as interleukin interleukin (IL)-1β and IL-6, which are elevated intraocularly in uveitis. In addition, it has been demonstrated that aqueous VEGF concentrations are statistically significantly higher in those uveitis patients with CME than those without CME. Inhibition of inappropriate VEGF activity is a potential approach to treatment of CME in uveitis given our current knowledge of the pathophysiology of this condition and also because of the clinical need for additional treatment options for these patients. Ranibizumab, a recombinant, humanized monoclonal antibody antigen-binding fragment (Fab) that neutralizes all active forms of VEGF-A, would target this pathway and may be useful in cases of persistent CME in uveitis patients.
The objective of this study is to determine if an anti-VEGF agent, Lucentis, is safe and effective in leading to regression of macular edema due to chronic non-infectious uveitis in patients with well-controlled uveitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months. | Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test. | 1 year | |
| The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months. |
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Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas A Albini, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bascom Palmer Eye Insitute | Miami | Florida | 33136 | United States | ||
| Bascom Palmer of the Palm Beaches |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. |
| 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 Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months. | Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015). | Posted | Mean | Standard Deviation | Change in ETDRS Letters | 1 year |
|
|
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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 | ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Floaters | Eye disorders | Systematic Assessment |
The main limitation of this study is the small number of patients.There is no comparative arm to better define the relative efficacy of ranibizumab as compared with intraocular steroids or other treatments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas A. Albini, MD | University of Miami | 3054825006 | talbini@med.miami.edu |
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| ID | Term |
|---|---|
| D014605 | Uveitis |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
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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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| 1 year |
| The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test. | 1 year |
| The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24. | 2 years |
| Palm Beach Gardens |
| Florida |
| 33418 |
| United States |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test. | Not Posted | 1 year |
| Secondary | The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months. | Not Posted | 1 year |
| Secondary | The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test. | Not Posted | 1 year |
| Secondary | The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24. | Not Posted | 2 years |
| 0 |
| 5 |
| 5 |
| 5 |
| Eye Pain | Eye disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Uveitis in fellow eye | Eye disorders | Systematic Assessment |
|
| Anterior uveitis | Eye disorders | Systematic Assessment |
|
| Dry Eye | Eye disorders | Systematic Assessment |
|
| Cataract | Eye disorders | Systematic Assessment |
|
| Glaucoma | Eye disorders | Systematic Assessment |
|
| Ocular pruritis | Eye disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
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| D012164 |
| Retinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |