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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of this study was to determine the safety of ranibizumab: a) as a surgical adjunct during cataract surgery in subjects with proliferative diabetic retinopathy (PDR) induced rubeosis and, b) in treatment of proliferative diabetic retinopathy (PDR).
This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in diabetic subjects presenting initially with dense cataract and proliferative diabetic retinopathy induced rubeosis. Ten subjects will be enrolled at a single center over a 10 month period. Patients will be followed for a total of 12 months in the treatment phase and will have safety follow-ups at Months 18 and 24. Eligibility for study entry will be determined by the principal investigator.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every month for 3 doses (loading dose on Day 0 and at Months 1 and 2) followed by as needed re-treatment based on specified criteria for the remainder of the study period. Subjects can receive a maximum of eight injections of ranibizumab during the study. All subjects will undergo cataract surgery after the first ranibizumab injection. Only one eye will be designated as the study eye for the duration of the study to receive the ranibizumab injections.
All subjects will be evaluated with best corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity, intraocular pressure measurement, ophthalmological examination, slit lamp photography, gonioscopy, fundus photography, fundus fluorescein angiography and Optical Coherence Tomography (OCT). An ultrasound will be done as needed. Best corrected ETDRS visual acuity and intraocular pressure measurements will be performed on both eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other | All subjects enrolled received treatment with identical dosage of Ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event (AE) | Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR). | first 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) | Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12 | months 3, 7 and 12 |
| Presence of Proliferative Diabetic Retinopathy (PDR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neelakshi Bhagat, MD, MPH | NJMS / UMDNJ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Njms / Umdnj | Newark | New Jersey | 07103 | United States |
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Subjects were recruited from the patients seen in the Ophthalmology Department at the University of Medicine and Dentistry of New Jersey.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Subjects With Treatment | All subjects received o.5 mg of ranibizumab injections monthly for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects With Treatment | All subjects received o.5 mg of ranibizumab injections monthly for 3 months |
| 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 | Adverse Event (AE) | Incidence and severity of AEs that were cataract surgery related (for instance, hyphema and vitreous hemorrhage) and AEs that occurred during the treatment of proliferative diabetic retinopathy (PDR). | All subjects' data was analyzed, no subjects were excluded | Posted | Number | participants | first 12 months |
|
|
Day 1 to Month-24
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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 | All Subjects With Treatment | All subjects received o.5 mg of ranibizumab injections monthly for 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot amputation surgery pre-scheduled prior to enrollment | Musculoskeletal and connective tissue disorders | Systematic Assessment | Hospitalization for a diabetic foot ulcer with a foot amputation scheduled prior to enrollment, 24 days after 1st injection. |
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Uncontrolled pilot study with a small sample size.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Neelakshi Bhagat | The University of Medicine and Dentistry of New Jersey | 973-972-2032 | bhagatne@umdnj.edu |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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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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Presence of proliferative diabetic retinopathy by fluorescein angiogram |
| at month-12 |
| Macular Volume | Macular volume (millimeters cubed [mm3]) by Stratus OCT | at months-1,3,7, and 12 |
| Mean Time to Re-treatment | Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months) | first 12 months |
| Mean Number of Ranibizumab Injections | Mean number of ranibizumab injections required through month 12 | first 12 months |
| Mean Number of PRP Laser Treatments | Mean number of PRP laser treatments required through month 12 | first 12 months |
| Mean Change in Intraocular Pressure (IOP) | Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12. | at months-3,7, and 12 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Presence of Neovascularization of Iris (NVI) or Neovascularization of the Angle (NVA) | Presence of neovascularization of iris (NVI) or neovascularization of the angle (NVA) as assessed by gonioscopy at months 3, 7 and 12 | All subjects' data was analyzed, no subjects were excluded | Posted | Number | participants | months 3, 7 and 12 |
|
|
|
| Secondary | Presence of Proliferative Diabetic Retinopathy (PDR) | Presence of proliferative diabetic retinopathy by fluorescein angiogram | All subjects' data was analyzed, no subjects were excluded | Posted | Number | participants | at month-12 |
|
|
|
| Secondary | Macular Volume | Macular volume (millimeters cubed [mm3]) by Stratus OCT | All subjects' data was analyzed, no subjects were excluded | Posted | Mean | Standard Deviation | Macular volume (millimeters cubed) | at months-1,3,7, and 12 |
|
|
|
| Secondary | Mean Time to Re-treatment | Mean time to re-treatment following the initial three monthly loading doses of ranibizumab (months) | All subjects' data was included | Posted | Mean | Standard Deviation | months | first 12 months |
|
|
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| Secondary | Mean Number of Ranibizumab Injections | Mean number of ranibizumab injections required through month 12 | All subjects' data was analyzed, no subjects were excluded | Posted | Mean | Standard Deviation | Number injections | first 12 months |
|
|
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| Secondary | Mean Number of PRP Laser Treatments | Mean number of PRP laser treatments required through month 12 | All subjects' data was analyzed, no subjects were excluded | Posted | Mean | Standard Deviation | PRP Laser treatments | first 12 months |
|
|
|
| Secondary | Mean Change in Intraocular Pressure (IOP) | Mean change in IOP (mm Hg) from baseline to months-3, 7, and 12. | All subjects' data was analyzed, no subjects were excluded | Posted | Mean | Standard Deviation | mmHg | at months-3,7, and 12 |
|
|
|
| 3 |
| 4 |
| 0 |
| 0 |
|
| Hospitalization for congestive heart failure attributed to uncontrolled diabetes | Cardiac disorders | Systematic Assessment | 2 months after 4th injection; 3 months after 4th injection: hospitalizations for CHF attributed to uncontrolled diabetes |
|
| Hospitalization for hyperkalemia and CHF, attributed to renal insufficiency | Cardiac disorders | Systematic Assessment | 2 months after 5th injection: hospitalization for hyperkalemia and CHF, attributed to renal insufficiency due to uncontrolled diabetes |
|
| Hospitalization for exacerbation of CHF | Cardiac disorders | Systematic Assessment | 4 months after 5th injection: hospitalization for exacerbation of CHF |
|
| Hospitalization for pleural effusion, CHF, and worsening of pre-existing foot ulcers (MRSA) | Cardiac disorders | Systematic Assessment | 5 months after 5th injection: hospitalization for pleural effusion, CHF and worsening of pre-existing bilateral foot ulcers which cultures identified as MRSA |
|
| Hospitalization for chronic osteomyelitis | Musculoskeletal and connective tissue disorders | Systematic Assessment | 14 months after 5th injection: hospitalization for chronic osteomyelitis |
|
| Hospitalization for congestive heart failure and renal insufficiency | Renal and urinary disorders | Systematic Assessment | 9 months after 3rd injection |
|
| Hospitalization for flare-up of pre-existing gastritis | Gastrointestinal disorders | Systematic Assessment | 15 months after 3rd injection: hospitalization for flare-up of pre-existing gastritis |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
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| Month 12 |
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