Retinal Detachment, Diabetic Retinopathy
Conditions
Keywords
Traction Retinal Detachment (PDR), Proliferative Diabetic Retinopathy (PDR)
Brief summary
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).
Detailed description
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.
Interventions
single 0.05 mL intravitreal injection of bevacizumab 1.25 mg
OTHERSham injection
Subject's eyes will be anesthetized but no injection will be performed.
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.
Exclusion criteria
* Dense vitreous hemorrhage * Inability to follow-up for surgery within 3-7 days after intravitreal injection * History of stroke, thromboembolic event, or heart attack within the last 6 months * Less than 18 years of age * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 months after last surgery | Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months from last surgery | Measured by median logMAR change in the best corrected visual acuity (VA) from baseline to post operative month 3 (POM3) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| 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. | 9 |
| 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. | 10 |
| Total | 39 |
Baseline characteristics
| Characteristic | Avastin Injection Group (AIG) | Sham Injection Group (SIG) | Total |
|---|---|---|---|
| Age, Continuous | 49 years | 53 years | 52 years |
| Sex: Female, Male Female | 2 Eyes | 6 Eyes | 8 Eyes |
| Sex: Female, Male Male | 8 Eyes | 4 Eyes | 12 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 3 months after last surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Avastin (Bevacizumab) | 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 | Vitreous VEGF levels | 0 pg/mL |
| Avastin (Bevacizumab) | 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 | Aqueous VEGF levels | 13 pg/mL |
| Sham Injection | 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 | Vitreous VEGF levels | 373 pg/mL |
| Sham Injection | 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 | Aqueous VEGF levels | 0 pg/mL |
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)
Time frame: 3 months from last surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Avastin (Bevacizumab) | Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery. | -0.18 logMAR |
| Sham Injection | Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery. | 0 logMAR |
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.
Time frame: 3 months after last surgery.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Avastin (Bevacizumab) | 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. | Cataract | 1 Eyes |
| Avastin (Bevacizumab) | 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. | Vitreous hemorrhage | 0 Eyes |
| Avastin (Bevacizumab) | 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. | Ischemia | 0 Eyes |
| Avastin (Bevacizumab) | 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. | Glaucoma | 0 Eyes |
| Sham Injection | 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. | Glaucoma | 1 Eyes |
| Sham Injection | 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. | Cataract | 1 Eyes |
| Sham Injection | 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. | Ischemia | 2 Eyes |
| Sham Injection | 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. | Vitreous hemorrhage | 1 Eyes |