A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Allergan

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: Dexamethasone; Other: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168389

206207-010

Details and patient eligibility

About

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of diabetic macular edema.

Enrollment: 494 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 18 years of age or older with diabetic macular edema;
• Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse);
• Visual acuity in other eye no worse than 20/200

Key Exclusion Criteria:

• Known anticipated need for ocular surgery within first 12 months of study;
• History of glaucoma or current high eye pressure requiring more than 1 medication;
• Uncontrolled systemic disease;
• Known steroid-responder;
• Use of systemic steroids
• Use of Warfarin/Heparin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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494 participants in 3 patient groups

Dexamethasone 700 μg

Experimental group

Description:

700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Treatment:

Drug: Dexamethasone

Dexamethasone 350 μg

Experimental group

Description:

350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.

Treatment:

Drug: Dexamethasone

Sham

Sham Comparator group

Description:

Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.

Treatment:

Other: Sham