Clinical trial NCT00801450: Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetic Macular Edema
Keywords: diabetes
macular edema
triamcinolone
cataract
refractory diabetic macular edema
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2008-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: central subfield macular thickness
timeFrame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
Secondary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively
measure: Intraocular pressure
timeFrame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
Study officials:
References:
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. No abstract available.
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.
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.
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. doi: 10.1136/bjo.2007.129122. Epub 2007 Oct 26.