Overview

This trial is active, not recruiting.

Condition diabetic macular edema
Treatments triamcinolone acetonide
Phase phase 1/phase 2
Sponsor University of Sao Paulo
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date September 2007
End date December 2008
Trial size 24 participants
Trial identifier NCT00801450, 2995/2007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
triamcinolone acetonide
4 mg
(Experimental)
triamcinolone acetonide
40 mg

Primary Outcomes

Measure
central subfield macular thickness
time frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively

Secondary Outcomes

Measure
Best Corrected Visual Acuity
time frame: baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively
Intraocular pressure
time frame: baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively

Eligibility Criteria

Male or female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by University of Sao Paulo.