Completed
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
What is being tested
Dexamethasone intravitreal implant
+ Steroid plus NSAID eye drop combination therapy
Drug
Who is being recruted
Endocrine System Diseases+7
+ Eye Diseases
+ Macular Degeneration
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: November 2012
Summary
Principal SponsorRetinal Consultants of Arizona
Last updated: April 5, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2012
Actual date on which the first participant was enrolled.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
Principal SponsorRetinal Consultants of Arizona
Last updated: April 5, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Endocrine System DiseasesEye DiseasesMacular DegenerationMetabolic DiseasesNutritional and Metabolic DiseasesRetinal DegenerationRetinal DiseasesGlucose Metabolism DisordersDiabetes MellitusMacular Edema
Criteria
3 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
Patient has any active infection in the study eye
Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication
Patient has other significant ocular disease in study eye, including glaucoma
Patient has received the OZURDEX implant before in the study eye
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalOZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
Group II
Active ComparatorNSAID eye drop: Acular LS Steriod eye drop: Pred Forte
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Retinal Consultants of Arizona
Phoenix, United StatesOpen Retinal Consultants of Arizona in Google MapsCompletedOne Study Center