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A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

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Allergan

Status and phase

Completed
Phase 3

Conditions

Macular Edema
Retinal Vein Occlusion

Treatments

Other: Sham Injection
Drug: 350 µg Dexamethasone
Drug: 700 µg Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00168324
206207-008

Details and patient eligibility

About

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Enrollment

599 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18 years of age or older with macular edema resulting from retinal vein occlusion
  • 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

Exclusion criteria

  • Known anticipated need for ocular surgery within next 12 months
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Diabetic retinopathy
  • 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

599 participants in 3 patient groups

700 µg Dexamethasone
Experimental group
Description:
700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
Treatment:
Drug: 700 µg Dexamethasone
350 µg Dexamethasone followed by 700 µg Dexamethasone
Experimental group
Description:
350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Treatment:
Drug: 700 µg Dexamethasone
Drug: 350 µg Dexamethasone
Sham Injection followed by 700 µg Dexamethasone
Sham Comparator group
Description:
Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
Treatment:
Drug: 700 µg Dexamethasone
Other: Sham Injection

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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