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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The purpose of the study is to study the safety of the combination of ranibizumab and MMC vs monotherapy MMC vs intravitreal ranibizumab injection in patients with glaucoma.
A common problem after undergoing trabeculectomy surgery to create a bleb (blister or bubble) to reduce intraocular pressure, is scarring of the opening. This scarring prevents fluid drainage and interferes with the proper functioning of the bleb. MMC (Mitomycin C) is usually administered intraoperatively, to reduce scarring and increase filtration. However, the failure rate of trabeculectomy remains high. Anti-VEGF (Vascular endothelial growth factor) agents have been used successfully in cases requiring bleb needling. The purpose of the study is to determine the safety of the combination of ranibizumab and MMC vs monotherapy MMC in patients with glaucoma.
This is an open-label, Phase I/II safety study of 30 patients randomized to either treatment with ranibizumab 0.5 mg intravitreally injected (n=10), combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) or MMC therapy alone (n=10).
For the ranibizumab groups, a repeat injection of ranibizumab 0.5mg may be given PRN (as needed) at 1 month if hypervascularity or neovascularization of the conjunctiva exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab alone | Experimental | Treatment with ranibizumab 0.5 mg intravitreally injected (n=10) |
|
| Ranibizumab and MMC | Experimental | Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) |
|
| MMC alone | Active Comparator | MMC therapy alone (n=10) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Ocular Adverse Events | To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months. | To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications) | 6 months |
| Mean Change in in Intraocular Pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malik Y. Kahook, MD | Rocky Mountain Lions Eye institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Lions Eye Institute | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20570237 | Derived | Kahook MY. Bleb morphology and vascularity after trabeculectomy with intravitreal ranibizumab: a pilot study. Am J Ophthalmol. 2010 Sep;150(3):399-403.e1. doi: 10.1016/j.ajo.2010.03.025. Epub 2010 Jun 8. |
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Subject medical information obtained by this study is confidential, and disclosure to third parties other than those noted below is prohibited.
Upon the subject's permission, medical information may be given to his/her personal physician or other appropriate medical personnel responsible for his/her welfare.
Data generated by this study will be available for inspection upon request by representatives of the U.S. FDA, national and local health authorities, the drug manufacturer and the IRB/EC, if appropriate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab Alone | Treatment with ranibizumab 0.5 mg intravitreally injected (n=10) Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed |
| FG001 | Ranibizumab and MMC | Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy |
| FG002 | MMC Alone | MMC therapy alone (n=10) MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab Alone | Treatment with ranibizumab 0.5 mg intravitreally injected (n=10) Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed |
| BG001 | Ranibizumab and MMC |
| 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 | Assessment of Ocular Adverse Events | To assess ocular adverse events of combination ranibizumab and MMC therapy at 6 months | Posted | Number | Number of Reported Adverse Events | 6 months |
|
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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 Alone | Treatment with ranibizumab 0.5 mg intravitreally injected (n=10) Ranibizumab: 0.5mg of ranibizumab intravitreally injected after surgery and at 1 month if needed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Malik Kahook | University of Colorado Denver | 720-848-2020 | malik.kahook@ucdenver.edu |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| D016685 | Mitomycin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ranibizumab and MMC | Drug | Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy |
|
|
| MMC | Drug | MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy. |
|
|
Mean change in in intraocular pressure at 3 months and at 6 months |
| 6 months |
| Mean Change in Visual Acuity | Mean change in visual acuity in logMAR. | 6 months |
Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10)
Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy
| BG002 | MMC Alone | MMC therapy alone (n=10) MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | MMC Alone | MMC therapy alone (n=10) MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy. |
|
|
| Secondary | Percent of Subjects With a Qualified Success and Viable Bleb at 6 Months. | To determine percent of subjects with a qualified success and viable bleb at 6 months (IOP between 6mm Hg and 22 mm Hg with pressure controlled with and without adjunctive medications) | Posted | Number | percentage of subjects | 6 months |
|
|
|
| Secondary | Mean Change in in Intraocular Pressure. | Mean change in in intraocular pressure at 3 months and at 6 months | Posted | Mean | Full Range | mmHg | 6 months |
|
|
|
| Secondary | Mean Change in Visual Acuity | Mean change in visual acuity in logMAR. | Posted | Mean | Full Range | logMAR | 6 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Ranibizumab and MMC | Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy (n=10) Ranibizumab and MMC: Combination ranibizumab 0.5mg intravitreally injected and MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy | 0 | 10 | 0 | 10 |
| EG002 | MMC Alone | MMC therapy alone (n=10) MMC: MMC (0.4 mg/ml for 2 min) in eyes after trabeculectomy. | 0 | 10 | 0 | 10 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D001389 | Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
|