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Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study) (IBEME)

Primary Purpose

Diabetic Macular Edema

Status

Unknown status

Phase

Phase 1

Locations

Brazil

Study Type

Interventional

Intervention

Intravitreal Injection of 1,5 mg of bevacizumab

Intravitreal injection of 4 mg of Triamcinolone acetonide

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring bevacizumab, diabetes, intravitreal, macular edema, triamcinolone, VEGF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Refractory diffuse DME (defined herein as clinically significant DME [by biomicroscopic evaluation] unresponsive to focal laser photocoagulation [performed at least 3 months before evaluation] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography),
Snellen logarithm of minimum angle of resolution (LogMAR) BCVA equivalent of 20/40 or worse, and 3) central macular thickness (CMT) greater than 300µm on optical coherence tomography (OCT)

Exclusion Criteria:

Aphakic or pseudophakic eyes,
Glycosylated hemoglobin (Hb A1C) rate above 10%,
History of glaucoma or ocular hypertension,
Loss of vision as a result of other causes,
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 (according to guidelines of the seventh report of the joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC-7]);16
Known coagulation abnormalities or current use of anticoagulative medication other than aspirin;
Severe systemic disease; or
Any condition affecting follow-up or documentation

Sites / Locations

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Outcomes

Primary Outcome Measures

Central Macular Thickness, Best Corrected Visual Acuity

Secondary Outcome Measures

Intraocular pressure; lens status

Full Information

NCT ID

NCT00468351

First Posted

May 1, 2007

Last Updated

May 1, 2007

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00468351

Brief Title

Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)

Acronym

IBEME

Official Title

Intravitreal Bevacizumab Versus Intravitreal Triamcinolone Acetonide for Refractory Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Unknown status

Study Start Date

April 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Sao Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and VE-cadherin. Based on these principles, there is a rationale for anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab injection for refractory diffuse DME.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

Keywords

bevacizumab, diabetes, intravitreal, macular edema, triamcinolone, VEGF

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Single

Allocation

Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Intravitreal Injection of 1,5 mg of bevacizumab

Intervention Type

Procedure

Intervention Name(s)

Intravitreal injection of 4 mg of Triamcinolone acetonide

Primary Outcome Measure Information:

Title

Central Macular Thickness, Best Corrected Visual Acuity

Time Frame

six months

Secondary Outcome Measure Information:

Title

Intraocular pressure; lens status

Time Frame

six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Refractory diffuse DME (defined herein as clinically significant DME [by biomicroscopic evaluation] unresponsive to focal laser photocoagulation [performed at least 3 months before evaluation] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography), Snellen logarithm of minimum angle of resolution (LogMAR) BCVA equivalent of 20/40 or worse, and 3) central macular thickness (CMT) greater than 300µm on optical coherence tomography (OCT) Exclusion Criteria: Aphakic or pseudophakic eyes, Glycosylated hemoglobin (Hb A1C) rate above 10%, History of glaucoma or ocular hypertension, Loss of vision as a result of other causes, 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 (according to guidelines of the seventh report of the joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC-7]);16 Known coagulation abnormalities or current use of anticoagulative medication other than aspirin; Severe systemic disease; or Any condition affecting follow-up or documentation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rodrigo Jorge, MD, PhD

Organizational Affiliation

HCFMRP-USP

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Rogério A Costa, MD, PhD

Organizational Affiliation

Retina Diagnostic and Treatment Division, Hospital de Olhos de Araraquara, Araraquara

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Rodrigo Jorge, MD, PhD

Organizational Affiliation

HCFMRP-USP

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

City

Ribeirão Preto

State/Province

São Paulo

ZIP/Postal Code

14049-900

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

17398322

Citation

Arevalo JF, Fromow-Guerra J, Quiroz-Mercado H, Sanchez JG, Wu L, Maia M, Berrocal MH, Solis-Vivanco A, Farah ME; Pan-American Collaborative Retina Study Group. Primary intravitreal bevacizumab (Avastin) for diabetic macular edema: results from the Pan-American Collaborative Retina Study Group at 6-month follow-up. Ophthalmology. 2007 Apr;114(4):743-50. doi: 10.1016/j.ophtha.2006.12.028.

Results Reference

background

PubMed Identifier

16186372

Citation

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.

Results Reference

background

PubMed Identifier

17290194

Citation

Costa RA, Jorge R, Calucci D, Melo LA Jr, Cardillo JA, Scott IU. Intravitreal bevacizumab (avastin) for central and hemicentral retinal vein occlusions: IBeVO study. Retina. 2007 Feb;27(2):141-9. doi: 10.1097/IAE.0b013e31802eff83.

Results Reference

background

PubMed Identifier

17151487

Citation

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.

Results Reference

background

PubMed Identifier

17003454

Citation

Costa RA, Jorge R, Calucci D, Cardillo JA, Melo LA Jr, Scott IU. Intravitreal bevacizumab for choroidal neovascularization caused by AMD (IBeNA Study): results of a phase 1 dose-escalation study. Invest Ophthalmol Vis Sci. 2006 Oct;47(10):4569-78. doi: 10.1167/iovs.06-0433.

Results Reference

background

PubMed Identifier

16978576

Citation

Audren F, Lecleire-Collet A, Erginay A, Haouchine B, Benosman R, Bergmann JF, Gaudric A, Massin P. Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg. Am J Ophthalmol. 2006 Nov;142(5):794-99. doi: 10.1016/j.ajo.2006.06.011. Epub 2006 Sep 15.

Results Reference

background

PubMed Identifier

17011952

Citation

Chun DW, Heier JS, Topping TM, Duker JS, Bankert JM. A pilot study of multiple intravitreal injections of ranibizumab in patients with center-involving clinically significant diabetic macular edema. Ophthalmology. 2006 Oct;113(10):1706-12. doi: 10.1016/j.ophtha.2006.04.033.

Results Reference

background

PubMed Identifier

16154196

Citation

Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, Goldbaum M, Guyer DR, Katz B, Patel M, Schwartz SD; Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005 Oct;112(10):1747-57. doi: 10.1016/j.ophtha.2005.06.007.

Results Reference

background

PubMed Identifier

17151486

Citation

Haritoglou C, Kook D, Neubauer A, Wolf A, Priglinger S, Strauss R, Gandorfer A, Ulbig M, Kampik A. Intravitreal bevacizumab (Avastin) therapy for persistent diffuse diabetic macular edema. Retina. 2006 Nov-Dec;26(9):999-1005. doi: 10.1097/01.iae.0000247165.38655.bf.

Results Reference

background

PubMed Identifier

19906082

Citation

Folgosa MS, Messias A, Takata C, Costa RA, Scott IU, Jorge R. Single intravitreal injection of triamcinolone combined with bevacizumab for the treatment of diffuse diabetic macular oedema refractory to grid photocoagulation. Acta Ophthalmol. 2010 Nov;88(7):e297-8. doi: 10.1111/j.1755-3768.2009.01721.x. No abstract available.

Results Reference

derived

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Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)

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