Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
1 other identifier
interventional
363
12 countries
13
Brief Summary
This study will compare the safety and efficacy of the 700 ug dexamethasone intravitreal implant with ranibizumab 0.5 mg intravitreal injections in patients with diabetic macular edema (DME).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2012
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedStudy Start
First participant enrolled
March 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2014
CompletedResults Posted
Study results publicly available
January 29, 2015
CompletedApril 17, 2019
April 1, 2019
1.9 years
December 13, 2011
January 21, 2015
April 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Baseline, 12 Months
Secondary Outcomes (2)
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye
Baseline, Month 12
Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)
Baseline, Month 12
Study Arms (2)
dexamethasone Intravitreal Implant
EXPERIMENTALInjection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
ranibizumab
ACTIVE COMPARATORInjection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
Interventions
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
Eligibility Criteria
You may qualify if:
- Diagnosis of type 1 or 2 diabetes mellitus
- Diagnosis of macular edema
- Visual acuity between 20/200 to 20/40
You may not qualify if:
- Eye surgery to the study eye within 3 months
- Use of Ozurdex® within 9 months
- Any active ocular inflammation and infection
- Diagnosis of glaucoma
- Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (13)
Unknown Facility
Arlington, Texas, United States
Unknown Facility
Brussels, Belgium
Unknown Facility
Copenhagen, Denmark
Unknown Facility
Glostrup Municipality, Denmark
Unknown Facility
Paris, France
Unknown Facility
Ahaus, Germany
Unknown Facility
Tel Aviv, Israel
Unknown Facility
Udine, Italy
Unknown Facility
Nijmegen, Netherlands
Unknown Facility
Coimbra, Portugal
Unknown Facility
Pretoria, South Africa
Unknown Facility
Barcelona, Spain
Unknown Facility
London, England, United Kingdom
Related Publications (3)
Callanan DG, Loewenstein A, Patel SS, Massin P, Corcostegui B, Li XY, Jiao J, Hashad Y, Whitcup SM. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2017 Mar;255(3):463-473. doi: 10.1007/s00417-016-3472-1. Epub 2016 Sep 8.
PMID: 27632215BACKGROUNDRittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
PMID: 33206392DERIVEDChakravarthy H, Devanathan V. Molecular Mechanisms Mediating Diabetic Retinal Neurodegeneration: Potential Research Avenues and Therapeutic Targets. J Mol Neurosci. 2018 Nov;66(3):445-461. doi: 10.1007/s12031-018-1188-x. Epub 2018 Oct 6.
PMID: 30293228DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 15, 2011
Study Start
March 9, 2012
Primary Completion
February 13, 2014
Study Completion
February 13, 2014
Last Updated
April 17, 2019
Results First Posted
January 29, 2015
Record last verified: 2019-04