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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT00801450

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Location

Arms

17.1

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Drug: Triamcinolone acetonide Drug: Triamcinolone acetonide	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2008

Anticipated Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravitreal (IVI)	Drug: Triamcinolone acetonide 4 mg
Experimental: SubTenon´s (STI)	Drug: Triamcinolone acetonide 40 mg

Arm

Intervention/Treatment

Experimental: Intravitreal (IVI)

Drug: Triamcinolone acetonide

4 mg

Experimental: SubTenon´s (STI)

Drug: Triamcinolone acetonide

40 mg

Outcome Measures

Primary Outcome Measures

central subfield macular thickness [baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively]

Secondary Outcome Measures

Best Corrected Visual Acuity [baseline and at 2, 4, 8±1, 12±2 and 24±2 weeks postoperatively]
Intraocular pressure [baseline and at 2, 4, 8±1 ,12±2 and 24±2 weeks postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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