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The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).
Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avastin Injection Group (AIG) | Experimental | Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
|
| Sham Injection Group (SIG) | Sham Comparator | Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avastin (bevacizumab) | Drug | single 0.05 mL intravitreal injection of bevacizumab 1.25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR | Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups. | 3 months after last surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery. | 3 months after last surgery. | |
| Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dean Eliott, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37260074 | Derived | Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4. | |
| 22965588 | Derived | Sohn EH, He S, Kim LA, Salehi-Had H, Javaheri M, Spee C, Dustin L, Hinton DR, Eliott D. Angiofibrotic response to vascular endothelial growth factor inhibition in diabetic retinal detachment: report no. 1. Arch Ophthalmol. 2012 Sep;130(9):1127-34. doi: 10.1001/archophthalmol.2012.1611. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Avastin Injection Group (AIG) | Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
| FG001 | Sham Injection Group (SIG) | Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Avastin Injection Group (AIG) | Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
| BG001 | Sham Injection Group (SIG) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR | Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups. | Posted | Median | Full Range | pg/mL | 3 months after last surgery | Eyes | Eyes |
|
3 months after surgery
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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 | Avastin Injection Group (AIG) | Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elliott Sohn | Doheny Eye Institute/USC/University of Iowa | 319-356-3185 | elliott-sohn@uiowa.edu |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Sham injection | Other | Subject's eyes will be anesthetized but no injection will be performed. |
|
|
Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3) |
| 3 months from last surgery |
Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Units | Eyes | Eyes |
|
|
|
| Secondary | Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery. | Posted | Count of Units | Eyes | 3 months after last surgery. | Eyes | Eyes |
|
|
|
| Secondary | Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery. | Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3) | Posted | Median | Full Range | logMAR | 3 months from last surgery | Eyes | Eyes |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sham Injection Group (SIG) | Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy. | 0 | 10 | 0 | 10 |
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| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Ischemia |
|
| Glaucoma |
|