N/A
N=19
Avastin for PDR (Proliferative Diabetic Retinopathy)
Retinal Detachment · Diabetic Retinopathy
Bottom Line
View on ClinicalTrials.gov: NCT01270542 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: 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 — 0; 373; 13; 0 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Avastin (bevacizumab) (Drug); Sham injection (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0; 373; 13; 0 | — |
| 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. |
1; 1; 0; 1; 0; 2 | — |
| SECONDARY Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery. |
-0.18; 0 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01270542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.