Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery - Full Text View

Sponsors and Collaborators:	University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00801450

Purpose

Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: Triamcinolone acetonide	Phase I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Cataract Edema Surgery

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:

central subfield macular thickness [ Time Frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Best Corrected Visual Acuity [ Time Frame: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively ] [ Designated as safety issue: Yes ]
Intraocular pressure [ Time Frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively ] [ Designated as safety issue: Yes ]

Enrollment:	24
Study Start Date:	September 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intravitreal (IVI): Experimental	Drug: Triamcinolone acetonide 4 mg
SubTenon´s (STI): Experimental	Drug: Triamcinolone acetonide 40 mg

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Refractory diffuse DME unresponsive to focal laser photocoagulation
Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm

Exclusion Criteria:

Previous ocular surgery
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
Severe systemic disease
Any condition affecting follow-up or documentation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801450

Locations

Brazil, São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14049-900

Sponsors and Collaborators

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

More Information

Publications:

Kumar V, Ghosh B, Raina UK, Goel N. Comparative therapy evaluation of intravitreal bevacizumab and triamcinolone acetonide on persistent diffuse diabetic macular edema. Am J Ophthalmol. 2008 Dec;146(6):974; author reply 974-5. No abstract available.

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. Epub 2006 Sep 15.

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.

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. Epub 2007 Oct 26.

Responsible Party:	University of São Paulo ( Rodrigo Jorge )
Study ID Numbers:	2995/2007
Study First Received:	December 2, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00801450 History of Changes
Health Authority:	Brazil: ANVISA

Keywords provided by University of Sao Paulo:

diabetes
macular edema
triamcinolone
cataract
refractory diabetic macular edema

Study placed in the following topic categories:

Anti-Inflammatory Agents
Immunologic Factors
Hormone Antagonists
Eye Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Edema
Macular Degeneration
Retinal Degeneration
Triamcinolone diacetate

Immunosuppressive Agents
Hormones
Glucocorticoids
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Cataract
Triamcinolone
Retinal Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Macular Degeneration
Retinal Degeneration
Enzyme Inhibitors
Triamcinolone diacetate

Immunosuppressive Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Triamcinolone hexacetonide
Macular Edema
Signs and Symptoms
Triamcinolone Acetonide
Therapeutic Uses
Triamcinolone
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009