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| ID | Type | Description | Link |
|---|---|---|---|
| 07-11-069 | Other Identifier | Massachusetts Eye and Ear Infirmary |
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The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | 10 Patients will receive treatment (Ranibizumab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 10 Patients will receive treatment (Ranibizumab) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing | 16 Weeks |
| Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs | 16 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs | Prospective | |
| Efficacy by Measuring Mean Change of BCVA | Prospective |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Dana, M.D., MPH | Massachusetts Eye and Ear Infirmary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear Infirmary | Boston | Massachusetts | 02114 | United States |
Participants were assigned to the investigational treatment upon a full eligibility screening. Participants were not eligible if they had received investigational therapy within 60 days, received treatment with anti-VEGF agents (intraocular or systemic) within 45 days, were concurrently using systemic anti-VEGF agents amongst other criteria.
Patients were recruited from the Cornea Service at the Massachusetts Eye and Ear Infirmary from April 2008 through September 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm | 10 eyes of 9 patients will receive treatment (Ranibizumab) Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | 10 Patients will receive treatment (Ranibizumab) Ranibizumab : 10 Patients will receive treatment (Ranibizumab) |
| 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 and Severity of Ocular Adverse Event | Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing | All participants enrolled into the study were analyzed. | Posted | Number | participants | 16 Weeks |
|
|
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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 | Treatment Arm | 10 eyes of 9 patients will receive treatment (Ranibizumab) Ranibizumab : 10 eyes of 9 patients will receive treatment (Ranibizumab) |
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Further and larger studies are needed to better establish the efficacy profile of this drug and optimize its dosing and formulation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Reza Dana | Massachusetts Eye and Ear Infirmary | 617-573-3313 | Cornea_Research@meei.harvard.edu |
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| ID | Term |
|---|---|
| D016510 | Corneal Neovascularization |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
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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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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs | Not Posted | 16 Weeks |
| Secondary | Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs | Not Posted | Prospective |
| Secondary | Efficacy by Measuring Mean Change of BCVA | Not Posted | Prospective |
| 0 |
| 9 |
| 0 |
| 9 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |