Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema

Allergan

Status and phase: Completed; Phase 2

Conditions: Vitrectomy; Diabetic Macular Edema

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799227

206207-018

Details and patient eligibility

About

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older with diabetic macular edema
• History of vitrectomy
• Central retinal thickness ≥ 275 µm
• Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye

Exclusion criteria

• Known anticipated need for ocular surgery during the study period
• History of glaucoma or current high eye pressure requiring more than 1 medication
• Uncontrolled systemic disease
• Known allergy to the study medication
• Known steroid-responder
• Use of systemic steroids
• Female subjects that are pregnant, nursing or planning a pregnancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

700 µg Dexamethasone Implant

Experimental group

Description:

700 µg dexamethasone implant in the study eye at Day 1

Treatment:

Drug: Dexamethasone