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

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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

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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