- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04856397
Ozurdex in Suboptimal Diabetic Macular Edema Patients (DME)
Ozurdex in Suboptimal Diabetic Macular Edema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Diabetic macular edema (DME) is the most common cause of vision loss in young patients with diabetes. Its pathophysiology starts with decreased retinal oxygen tension that manifests as retinal capillary hyperpermeability and increased intravascular pressure mediated by vascular endothelial growth factor (VEGF) upregulation and retinal vascular autoregulation, respectively. Spectral domain optical coherence tomography (SD-OCT) is the cornerstone of clinical assessment of DME. The foundation of treatment is metabolic control of hyperglycemia and blood pressure. Specific ophthalmic treatments of DME include intravitreal anti-VEGF drug injections, in the form of intravitreal Bevacizumab (Avastin), Ranibizumab (Lucentis), and Aflibercept (Eylea). Intravitreal corticosteroid injections, focal laser photocoagulation, and vitrectomy are other treatment options. A substantial fraction of eyes respond incompletely to all of these modalities resulting in visual loss and disordered retinal structure and vasculature visible on SD-OCT and OCT angiography. There is currently no consensus on when to switch from one treatment to another in the context of a suboptimal response. Our hypothesis is that patients who are switched early to Ozurdex and achieve an OCT proven dry state, achieve better functional outcomes than those patients who are switched late or not at all, by limiting exposure of the retina to potentially damaging inflammatory markers, and the merits associated with less frequent injections.
Suboptimal DME is defined as a central subfoveal retinal thickness of > 300 and the presence of intra or sub-retinal fluid with a minimum BCVA of 20/25 or worse after 3 injections of intravitreal aflibercept, from here on referred to as Eylea. Furthermore, there is some evidence that a subset of patients with refractory DME respond well to intravitreal corticosteroids, specifically, Ozurdex, which is a biodegradable, sustained-release intravitreal dexamethasone implant, designed to be potentially injected between 2-6 months. This medication is currently not covered by the Ontario health benefits plan for patients with DME and comes at a significant cost to patients.
Moreover, recent studies have confirmed the important role of inflammatory ocular cytokines in patients' response to intravitreal treatments in DME, much the same as neovascular age-related macular degeneration. However, it is not known which ocular cytokines determine the degree of response to various treatment modalities for DME.
Here, investigators aim to study the anatomic and visual outcomes, as well as the cytokine profile of patients with suboptimal DME in response to early vs. late switch to intravitreal Ozurdex treatment.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Treatment-native patients with DME secondary to type I or type II diabetes mellitus
- Patients who require intravitreal anti-VEGF treatment
- Able to understand English and complete a pain assessment
- Suboptimal DME responders in patients who have received 3 or 6 eylea injections (non-cytokine group)
Exclusion Criteria:
- Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery; all patients who may need translation, are illiterate, or unable to provide consent.
- Pre-existing ocular pathology confounding outcome (i.e. uveitis, retinal vascular disease, macular degeneration etc.)
- Pre-existing uncontrolled glaucoma/high IOP
- Patients under 18
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control group
Responders will be in this category.
These patients will be maintained on intravitreal anti-VEGF therapy for 1 year, with a monthly PRN ("as needed") treatment regimen post 5 monthly loading doses.
|
anti-VEGF medication
|
Experimental: Early switch
Suboptimal responders who are switched to intravitreal Ozurdex (monitored monthly and treated PRN at a potential 2-6 month interval) injections after the first 3 monthly loading intravitreal eylea.
|
anti-VEGF medication
Dexamethasone intravitreal implant
Other Names:
|
Experimental: Late switch
Suboptimal responders who are switched to intravitreal Ozurdex (monitored monthly and treated PRN at a potential 2-6 month interval) injections after the first 6 monthly loading intravitreal eylea
|
anti-VEGF medication
Dexamethasone intravitreal implant
Other Names:
|
Other: Non-switch
Suboptimal responders who continue to receive monthly intravitreal anti-VEGF injections.
|
anti-VEGF medication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: 1 year
|
best corrected visual acuity (BCVA)
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OCT findings
Time Frame: 1 year
|
Track anatomic outcomes on optical coherence tomography (OCT)
|
1 year
|
OCTa findings
Time Frame: 1 year
|
Track anatomic outcomes on optical coherence tomography angiography (OCTA)
|
1 year
|
Cytokine expression TNFa
Time Frame: 1 year
|
baseline cytokine profile of the aqueous humour of all patients prior to first dose of anti-VEGF.
Cytokine TNFa
|
1 year
|
Cytokine expression IL-8
Time Frame: 1 year
|
baseline cytokine profile of the aqueous humour of all patients prior to first dose of anti-VEGF.
Cytokine IL-8
|
1 year
|
Cytokine expression IL-6
Time Frame: 1 year
|
baseline cytokine profile of the aqueous humour of all patients prior to first dose of anti-VEGF.
Cytokine IL-6
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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