Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A536070 | Other Identifier | UW Madison | |
| SMPH/OPHTHAL&VIS SCI | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab | Experimental | Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner. |
|
| Chart review | No Intervention | Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery | Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael Altaweel, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23582767 | Background | Pennock S, Kim D, Mukai S, Kuhnle M, Chun DW, Matsubara J, Cui J, Ma P, Maberley D, Samad A, Van Geest RJ, Oberstein SL, Schlingemann RO, Kazlauskas A. Ranibizumab is a potential prophylaxis for proliferative vitreoretinopathy, a nonangiogenic blinding disease. Am J Pathol. 2013 May;182(5):1659-70. doi: 10.1016/j.ajpath.2013.01.052. Epub 2013 Apr 9. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
The comparison arm is a chart review, participants were not enrolled in prospective study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Bevacizumab | Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner. Bevacizumab |
| FG001 | Chart Review | Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Bevacizumab | Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner. Bevacizumab |
| 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 | Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery | Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures. | Posted | Count of Participants | Participants | 6 months |
|
up to 6 months
Comparison arm is a retrospective cohort, no prospective intervention evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bevacizumab | Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner. Bevacizumab |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael M Altaweel, MD | University of Wisconsin - Madison | (608) 263-7290 | mmaltaweel@wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2017 | Feb 25, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D018630 | Vitreoretinopathy, Proliferative |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG001 | Chart Review | Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery.
|
|
| Secondary | Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Chart Review | Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |