Intravitreal Bevacizumab and Triamcinolone Associated to Laser Photocoagulation for Diabetic Macular Edema(IBeTA)
NCT ID: NCT00997191
Last Updated: 2013-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
12 participants
INTERVENTIONAL
2009-10-31
2011-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)
NCT00468351
Intravitreal Bevacizumab and Triamcinolone in Diabetic Macular Edema
NCT01342159
Efficacy Study of Triamcinolone and Bevacizumab Intravitreal for Treatment of Diabetic Macular Edema
NCT00737971
Short-term Effects of Intravitreal Bevacizumab and Triamcinolone in Patients With Diabetic Macular Edema
NCT00563940
Combined Therapy of Posterior Subtenon Triamcinolone Acetonide and Intravitreal Bevacizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion
NCT01614509
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Laser photocoagulation is the standard of care treatment for diabetic macular edema, based on ETDRS and recent clinical trials findings3,4. However, because visual acuity improvement post-laser is observed infrequently, and because of the frequent recurrence or persistence of DME (refractory DME) after appropriate laser treatment, particularly in eyes presenting with angiographically diffuse macular edema5-9, there is a need for alternative treatments for the management of DME. In addition, for some patients with significant cataract, precise visualization of posterior pole structures may not be possible, so that pharmacological therapy with intravitreal agents may be preferable over laser treatment.
Recent studies have shown promising results of pharmacological therapies for Diabetic macular edema. Triamcinolone has shown similar results when compared to ranibizumab and deferred focal/grid LASER in pseudophakic eyes (DRCRnet, prompt versus deferred). Ranibizumab associated with deferred LASER or as monotherapy has also shown promising results (RISE and RIDE). However, there are several concerns regarding long-term intravitreal injections therapies that include economic feasibility for the public health system, risk of endophthalmitis and patient acceptability. For these reasons, the present study decided to check associations between LASER and drug therapy, in an attempt to improve focal/grid laser outcomes with reduced number of intravitreal injections.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Laser Group
Focal / grid Laser photocoagulation in diabetic macular edema
Laser photocoagulation
Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines
Triamcinolone group
Intravitreal triamcinolone associated to laser photocoagulation for diabetic macular edema
Intravitreal triamcinolone
Intravitreal preservative-free triamcinolone (4mg) associated to focal photocoagulation for diabetic macular edema on baseline; Re-treatment at weeks 20 and 40 if CMT\>275um
Bevacizumab group
Intravitreal Bevacizumab associated to laser photocoagulation for diabetic macular edema
Intravitreal bevacizumab
Intravitreal bevacizumab (1.5mg) associated to focal photocoagulation for diabetic macular edema at baseline; Re-treatment at weeks 20 and 40 if CMT\>275um
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laser photocoagulation
Focal / grid photocoagulation for diabetic macular edema according to ETDRS guidelines
Intravitreal triamcinolone
Intravitreal preservative-free triamcinolone (4mg) associated to focal photocoagulation for diabetic macular edema on baseline; Re-treatment at weeks 20 and 40 if CMT\>275um
Intravitreal bevacizumab
Intravitreal bevacizumab (1.5mg) associated to focal photocoagulation for diabetic macular edema at baseline; Re-treatment at weeks 20 and 40 if CMT\>275um
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Snellen logarithm of minimum angle of 20/40 or worse
* Central macular thickness greater than 275 µm on optical coherence tomography (OCT)
Exclusion Criteria
* History of glaucoma or ocular hypertension
* Systemic corticoid therapy
* History of thromboembolic event (including myocardial infarction or cerebral vascular accident)
* Major surgery within the prior 6 months or planned within the next 28 days
* Uncontrolled hypertension
* Severe systemic disease
* Any condition affecting documentation or follow-up
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação de Amparo à Pesquisa do Estado de São Paulo
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rodrigo Jorge
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Maria L Paccola, MD
Role: STUDY_CHAIR
HC FMRP - USP
André M V Messias, PhD
Role: STUDY_CHAIR
HCFMRP - USP
Bianka Y N Y Katayama, MD
Role: STUDY_DIRECTOR
HC FMRP - USP
Rodrigo Jorge, PhD
Role: PRINCIPAL_INVESTIGATOR
HC FMRP - USP
Rogério A Costa, PhD
Role: STUDY_CHAIR
HC FMRP - USP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Paccola L, Costa RA, Folgosa MS, Barbosa JC, Scott IU, Jorge R. Intravitreal triamcinolone versus bevacizumab for treatment of refractory diabetic macular oedema (IBEME study). Br J Ophthalmol. 2008 Jan;92(1):76-80. doi: 10.1136/bjo.2007.129122. Epub 2007 Oct 26.
Bonini-Filho MA, Jorge R, Barbosa JC, Calucci D, Cardillo JA, Costa RA. Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical trial. Invest Ophthalmol Vis Sci. 2005 Oct;46(10):3845-9. doi: 10.1167/iovs.05-0297.
Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.
Garner A. Pathology of diabetic retinopathy. Br Med Bull. 1970 May;26(2):137-42. doi: 10.1093/oxfordjournals.bmb.a070765. No abstract available.
Early photocoagulation for diabetic retinopathy. ETDRS report number 9. Early Treatment Diabetic Retinopathy Study Research Group. Ophthalmology. 1991 May;98(5 Suppl):766-85.
Jorge R, Costa RA, Calucci D, Cintra LP, Scott IU. Intravitreal bevacizumab (Avastin) for persistent new vessels in diabetic retinopathy (IBEPE study). Retina. 2006 Nov-Dec;26(9):1006-13. doi: 10.1097/01.iae.0000246884.76018.63.
Jonas JB, Kreissig I, Sofker A, Degenring RF. Intravitreal injection of triamcinolone for diffuse diabetic macular edema. Arch Ophthalmol. 2003 Jan;121(1):57-61.
Lee CM, Olk RJ. Modified grid laser photocoagulation for diffuse diabetic macular edema. Long-term visual results. Ophthalmology. 1991 Oct;98(10):1594-602. doi: 10.1016/s0161-6420(91)32082-7.
Kang SW, Sa HS, Cho HY, Kim JI. Macular grid photocoagulation after intravitreal triamcinolone acetonide for diffuse diabetic macular edema. Arch Ophthalmol. 2006 May;124(5):653-8. doi: 10.1001/archopht.124.5.653.
Karacorlu M, Ozdemir H, Senturk F, Arf Karacorlu S, Uysal O. Macular function by multifocal electroretinogram in diabetic macular edema after intravitreal triamcinolone acetonide injection. Eur J Ophthalmol. 2008 Jul-Aug;18(4):601-8. doi: 10.1177/112067210801800417.
Martidis A, Duker JS, Greenberg PB, Rogers AH, Puliafito CA, Reichel E, Baumal C. Intravitreal triamcinolone for refractory diabetic macular edema. Ophthalmology. 2002 May;109(5):920-7. doi: 10.1016/s0161-6420(02)00975-2.
Kook D, Wolf A, Kreutzer T, Neubauer A, Strauss R, Ulbig M, Kampik A, Haritoglou C. Long-term effect of intravitreal bevacizumab (avastin) in patients with chronic diffuse diabetic macular edema. Retina. 2008 Oct;28(8):1053-60. doi: 10.1097/IAE.0b013e318176de48.
Larsson J, Zhu M, Sutter F, Gillies MC. Relation between reduction of foveal thickness and visual acuity in diabetic macular edema treated with intravitreal triamcinolone. Am J Ophthalmol. 2005 May;139(5):802-6. doi: 10.1016/j.ajo.2004.12.054.
Soheilian M, Ramezani A, Bijanzadeh B, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Tabatabaei H, Peyman GA. Intravitreal bevacizumab (avastin) injection alone or combined with triamcinolone versus macular photocoagulation as primary treatment of diabetic macular edema. Retina. 2007 Nov-Dec;27(9):1187-95. doi: 10.1097/IAE.0b013e31815ec261.
Vujosevic S, Pilotto E, Bottega E, Benetti E, Cavarzeran F, Midena E. Retinal fixation impairment in diabetic macular edema. Retina. 2008 Nov-Dec;28(10):1443-50. doi: 10.1097/IAE.0b013e318183571e.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6826/2009
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.