Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

Heidelberg University

Status and phase: Unknown; Phase 1

Conditions: Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Drug: Intravitreal injection (triamcinolone acetonide)

Study type: Interventional

Funder types: Other

Identifiers

NCT00476918

21091968

Insurance no.: 20-770-968594

Details and patient eligibility

About

Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.

Full description

Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.

In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years

Exclusion criteria

• recent treatment with laser photocoagulation or intravitreal drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind