CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 599 enrolled
Drug / intervention
700 µg Dexamethasone +2 moredrug
Likely dose
700 µg dexamethasone intravitreal implant on Day 0 and/or Day 180AI-extracted
Key inclusion· 4
  • ✓Age 18 years or older
  • ✓Macular edema resulting from retinal vein occlusion
  • ✓Decreased visual acuity in at least one eye (20/50 or worse) due to macular edema
  • ✓Visual acuity in the other eye no worse than 20/200
Key exclusion· 7
  • ✕Anticipated need for ocular surgery within the next 12 months
  • ✕History of glaucoma or current high eye pressure requiring more than 1 medication
  • ✕Diabetic retinopathy
  • ✕Uncontrolled systemic disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00168324
NCT00168324Phase 3Completed
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A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Allergan·interventional·Posted Sep 15, 2005·Updated Apr 23, 2019

In Brief

A Phase 3 clinical trial evaluating 700 µg Dexamethasone, 350 µg Dexamethasone, and 1 other intervention for Macular Edema and Retinal Vein Occlusion. Completed, enrolled 599 participants across 13 sites in 13 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema, Retinal Vein Occlusion
CountriesAustralia, Austria, Canada, Czechia, France, Germany, Israel, Mexico, Philippines, Portugal, South Africa, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartOct 1, 2004
Primary CompletionMar 1, 2008
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.8 years ago

Interventions

700 µg Dexamethasonedrug

700 µg dexamethasone intravitreal implant administered on Day 0 and/or Day 180.

350 µg Dexamethasonedrug

350 µg Dexamethasone intravitreal implant administered on Day 0.

Sham Injectionother

Sham injection on Day 0.