Bevacizumab as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
|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: NCT01389505|
Recruitment Status : Unknown
Verified January 2011 by Instituto do Coracao.
Recruitment status was: Recruiting
First Posted : July 8, 2011
Last Update Posted : July 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Proliferative Diabetic Retinopathy||Procedure: Panretinal photocoagulation Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab||Phase 2|
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal Bevacizumab plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity and contrast vision measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.
Patients with similar proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and intravitreal Bevacizumab injections in one eye. For the Bevacizumab injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Structural and Functional Evaluation of the Macula in Patients With Proliferative Diabetic Retinopathy Treated With Panretinal Photocoagulation and Bevacizumab (Avastin ®)|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||September 2012|
|Estimated Study Completion Date :||September 2012|
Active Comparator: Panretinal photocoagulation
Group 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3.
Procedure: Panretinal photocoagulation
Three episodes of panretinal photocoagulation with one week of interval
Experimental: Bevacizumab + Panretinal Photocoagulation (PRP)
Group 2: Bevacizumab intravitreous injections plus PRP
Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab
Intravitreous injection of Bevacizumab 1 week before and the other at the same day of the third episode of PRP
- Functional Macular Evaluation [ Time Frame: 24 weeks ]During this 24 weeks of follow-up the Visual acuity (ETDRS), Contrast vision will be measured at baseline, 4, 12 and finally at 24 week
- Structural Macular Evaluation [ Time Frame: 24 weeks ]During the 24 weeks of follow-up the following measured will be made: Optical coherence tomography, need of vitrectomy, need panretianal photocoagulation retreatment, adverse events, recurrence of neovascularizaton, need or additional focal and grid macular laser for diabetic macular edema
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): NCT01389505
|Contact: Rony C Preti, MDfirstname.lastname@example.org|
|Contact: University Sao Paulo||+551130696000|
|University of Sao Paulo||Recruiting|
|Sao Paulo, SP, Brazil, 05403-000|
|Contact: Rony C Preti, MD +551199991636 email@example.com|
|Sub-Investigator: Rony C Preti, MD|
|Principal Investigator:||Walter Y Takahashi, PhD||University of Sao Paulo|