CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 554 enrolled
Drug / intervention
Dexamethasone +1 moredrug
Likely dose
Dexamethasone 350 µg or 700 µg posterior segment implant, injected intravitreally at least every 6 months for up to 36 monthsAI-extracted
Key inclusion· 3
  • ✓Age ≥18 years with diabetic macular edema
  • ✓Decreased visual acuity (20/50 or worse) in at least one eye due to macular edema
  • ✓Visual acuity in the other eye no worse than 20/200
Key exclusion· 6
  • ✕Anticipated need for ocular surgery within next 12 months
  • ✕History of glaucoma or current high intraocular pressure requiring more than one medication
  • ✕Uncontrolled systemic disease
  • ✕Known steroid-responder

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

Search/NCT00168337
NCT00168337Phase 3Completed
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A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

Allergan·interventional·Posted Sep 15, 2005·Updated Aug 4, 2014

In Brief

A Phase 3 clinical trial evaluating Dexamethasone and Sham for Diabetic Macular Edema. Completed, enrolled 554 participants across 14 sites in 14 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesBrazil, Canada, Colombia, France, Hungary, India, Italy, New Zealand, Poland, Singapore, South Korea, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 15, 2005
Enrollment StartMay 1, 2005
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 20.8 years ago

Interventions

Dexamethasonedrug

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

Shamother

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.