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Completed

NCT Number: NCT01673191

A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

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Key information

Conditions

Macular Edema Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Degeneration Metabolic Diseases Nutritional and Metabolic Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

About this study

The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has diagnosis of Diabetes Mellitus, Type I or II.
  • Patient has experienced the development of macular edema following cataract surgery in at least one eye.
  • Patient has had cataract surgery within 90 days prior to the screening visit.

Exclusion criteria

  • Patient has other significant ocular disease in study eye, including glaucoma.
  • Patient has any active infection in the study eye.
  • Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).
  • Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.
  • Patient has received the OZURDEX® implant before in the study eye.

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

Other names: OZURDEX

Steroid plus NSAID eye drop combination therapy

Drug

Other names: Acular LS and Pred Forte

Primary outcomes

  1. Mean Change in Best Corrected Visual Acuity

    Time frame: 1 months

  2. Mean Change in Best Corrected Visual Acuity

    Time frame: 2 months

  3. Mean Change in Best Corrected Visual Acuity

    Time frame: 3 months

  4. Mean Change in Central Retinal Thickness

    Time frame: 1 month

  5. Mean Change in Central Retinal Thickness

    Time frame: 2 months

  6. Mean Change in Central Retinal Thickness

    Time frame: 3 months

  7. Mean Change in Intraocular Pressure

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Retinal Consultants of Arizona

Other

Collaborators

  • Allergan

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 27, 2012
Registry last updated
Apr 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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