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

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00801450
• Other study ID #: 2995/2007
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: December 2, 2008
• Last updated: October 8, 2009
• Start date: September 2007
• Est. completion date: February 2009

Study information

• Verified date: October 2009
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Triamcinolone acetonide
4 mg
• Triamcinolone acetonide
40 mg

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View 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. — View Citation

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. doi: 10.1016/j.ajo.2008.08.013. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central subfield macular thickness		baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively	No
Secondary	Best Corrected Visual Acuity		baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively	Yes
Secondary	Intraocular pressure		baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively	Yes