Effect of the Adjunctive IVB Before PRP
This study is to investigate the effect of adjunctive intravitreal bevacizumab (IVB) before panretinal photocoagulation (PRP) compared with only PRP on central macular thickness and retinal nerve fiber layer thickness in patients with severe diabetic retinopathy without macular edema.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness|
- Central macular thickness [ Time Frame: 6 months after first PRP session ] [ Designated as safety issue: No ]central macular thickness measured by Cirrus HD optical coherence tomography
- Retinal nerve fiber layer thickness [ Time Frame: 6 months after first PRP session ] [ Designated as safety issue: No ]retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.
|Study Start Date:||August 2011|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: IVB group
Patients were treated with IVB injections approximately within 1 week before the first PRP. Then patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.
intravitreal bevacizumab injection (1.25 mg/0.05 mL) was done 4.0 mm posterior to the corneal limbus using a 30-gauge needle after topical anesthesia
Other Name: Avastin; Genentech, Inc., South San Francisco, CA, USA
No Intervention: only PRP group
Patients had PRP, which was done in three sessions at weeks 0, 1, and 2 according to ETDRS guidelines. The superior, inferior, and nasal and temporal areas were treated sequentially.
This prospective randomized study included 30 patients (60 eyes) with severe nonproliferative diabetic retinopathy or non-high-risk proliferative diabetic retinopathy. They had weekly PRP treatments in 3 sessions and they were randomly assigned to IVB group who had adjunctive IVB within 1 week before first PRP and control group who had only PRP. CMT, RNFL, and best-corrected visual acuity (BCVA) were measured
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504724
|Korea, Republic of|
|Dong Ho Park|
|Daegu, Korea, Republic of, 700-721|
|Principal Investigator:||Dong Ho Park, M.D.||Kyungpook National University|