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The purpose of this study is to see if a new add on (or adjunctive) therapy used in glaucoma surgery improves the success of needle bleb revisions.
To investigate the efficacy of needle bleb revisions with mitomycin C with subconjunctival bevacizumab in promoting both filtering success and favorable bleb morphologic features.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Active Comparator | subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. |
|
| balanced salt solution | Placebo Comparator | patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Drug | 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) | mmHg (millimeters of mercury) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Surgical Success | Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlene R Moster, MD | Wills Eye | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Institute, Glaucoma Service | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25826644 | Result | Tai TY, Moster MR, Pro MJ, Myers JS, Katz LJ. Needle bleb revision with bevacizumab and mitomycin C compared with mitomycin C alone for failing filtration blebs. J Glaucoma. 2015 Apr-May;24(4):311-5. doi: 10.1097/IJG.0b013e31829f9bd3. |
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Eligible patients were recruited between February 2009 and July 2011 from the Glaucoma Service located at Wills Eye Hospital in Philadelphia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment A (Bevacizumab) | patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. |
| FG001 | Treatment B (Balanced Salt Solution) | patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 patients withdrew; 3 from Treatment A group and 2 from Treatment B group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment A (Bevacizumab) | patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. |
| BG001 | Treatment B (Balanced Salt Solution) |
| 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 | Intraocular Pressure (IOP) | mmHg (millimeters of mercury) | Posted | Mean | 95% Confidence Interval | mmHg (millimeters of mercury) | 6 months |
|
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At each of the five post-operative follow-up visits, patients were assessed for visual acuity, intraocular pressure, anterior chamber depth, hypotony changes, endothelial folds, hyphema, flare, cells, optic nerve swelling, choroidal folds, choroidal detachment and macular/retina folds.
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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 A (Bevacizumab) | patients randomized to treatment A are given 1.0mg (0.04cc of 25 mg/mL) subconjunctival bevacizumab injection either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyphema | Eye disorders | Systematic Assessment |
Small sample size which did not allow further subgroup analysis based on these patient characteristics.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlene R. Moster, MD | Wills Eye Hospital | 215-928-3123 | marlenemoster@gmail.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C072670 | Hanks Balanced Salt Solution |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| balanced salt solution | Other | 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure |
|
| 6 months |
patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Number of Participants With Surgical Success | Surgery was rated as complete success, qualified success or failure. Complete success was defined as 20% (percent) reduction in eye pressure (IOP) without any IOP lowering medications. Qualified success was defined as 20% reduction of IOP with IOP lowering medications. Failure was defined as IOP greater than 21 mmHG (millimeters of mercury), less than 20% IOP reduction or need for additional surgery. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 17 |
| 29 |
| EG001 | Treatment B (Balanced Salt Solution) | patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C. | 0 | 29 | 0 | 29 | 15 | 29 |
| Shallow Anterior Chamber | Eye disorders | Systematic Assessment |
|
| Shallow Anterior Chamber necessitating injection of viscoelastic | Eye disorders | Systematic Assessment |
|
| Endothelial folds | Eye disorders | Systematic Assessment |
|
| Retinal/Choroidal folds | Eye disorders | Systematic Assessment |
|
| Choroidals | Eye disorders | Systematic Assessment |
|
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Failure |
|