Effect of the Adjunctive IVB Before PRP (IVB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01504724|
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: bevacizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Adjunctive Intravitreal Bevacizumab Before Panretinal Photocoagulation in Macular Thickness and Retinal Nerve Fiber Layer Thickness|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2013|
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.
- Central macular thickness [ Time Frame: 6 months after first PRP session ]central macular thickness measured by Cirrus HD optical coherence tomography
- Retinal nerve fiber layer thickness [ Time Frame: 6 months after first PRP session ]retinal nerve fiber layer thickness measured by Cirrus HD optical coherence tomography.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504724
|Korea, Republic of|
|Dong Ho Park|
|Daegu, Korea, Republic of, 700-721|
|Principal Investigator:||Dong Ho Park, M.D.||Kyungpook National University|