Last updated: April 8, 2024
Sponsor: Texas Retina Associates
Overall Status: Completed
Phase
4
Condition
Diabetic Macular Edema
Diabetic Retinopathy
Macular Edema
Treatment
Eylea
Ozurdex
Clinical Study ID
NCT03984110
TRA-COED-19-001
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Type 1 or 2 diabetic patients
- At least 18 years of age, understands the language of the informed consent, and iswilling and able to provide written informed consent before any study procedures
- Pseudophakic or phakic lens status with intact posterior lens capsule and/or Nd:Yttrium Aluminum Garnet (YAG) laser capsulotomy that in the investigator's opinion isnot likely to permit dislocation of Ozurdex implant into the anterior chamber
- Center-involving DME > 300 µm
- Baseline BCVA between 20/40 - 20/320
- Eyes with intraocular pressure (IOP) ≤ 21 and / or treatment with < 2 topicalIOP-lowering medications (eyes with history of previous angle -closure or similarconditions that have been successfully treated with either laser or surgicalintervention are allowed as long as the visual fields and optic nerves have beenstable for > 1 year prior to study entry and the patient has been and can be safelydilated)
Exclusion
Exclusion Criteria:
- Patients with active or suspected ocular or periocular infections including most viraldiseases of the cornea and conjunctiva, including active epithelial herpes simplexkeratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, andfungal diseases.
- Patients with known hypersensitivity to any components of Eylea or Ozurdex
- Patient has suffered from a stroke or transient ischemic attack (TIA) in the last 6months
- Patients using topical anti-inflammatory medication for the duration of the study
- Patients with Anterior Chamber Intraocular Lens (ACIOL) and rupture of the posteriorlens capsule
- Prior panretinal photocoagulation or macular laser treatments within 90 days ofscreening
- Previous vitrectomy
- Any ocular condition that in the opinion of the investigator would not permitimprovement of visual acuity with resolution of DME (e.g., foveal atrophy, pigmentabnormalities, dense subfoveal hard exudates and/or poor foveal architecturesuggestive of photoreceptor loss)
- Patients with retinal diseases other than diabetes that can affect macular edema
- Eyes with a history of advanced glaucoma (optic nerve head change consistent withglaucoma damage and/or glaucomatous visual field loss), uncontrolled ocularhypertension (baseline IOP > 21 mmHg despite use of ≥ 2 topical IOP-loweringmedication)
- Eyes with a history of steroid response (i.e., increase of ≥ 5 mmHg IOP followingtopical steroid treatment)
- Female patients who are pregnant or breastfeeding
- Patients who are unable to attend scheduled follow-up visits throughout the 24-weekstudy
- Any intravitreal anti-Vascular Endothelial Growth Factor (VEGF) treatment to study eyewithin 3 months prior to Day 1
- Use of systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior toenrollment or anticipated use during the study (these drugs are prohibited from useduring the study)
- History of any previous treatment in the study eye with an ocular corticosteroidimplant (eg Iluvien, Ozurdex, Retisert)
- Has scarring from laser photocoagulation in the study eye that would compromise VisualAcuity (VA); or scarring or abnormality from other macular condition, in theinvestigator's medical judgement, would limit VA (such as an epiretinal membrane ormacular hole)
- Has significant media opacity precluding evaluation of retina and vitreous in thestudy eye. This includes cataract that is felt to be a major contributor to reducedvisual acuity and/or likely to undergo surgical repair within 3 months ofrandomization.
- Has any uncontrolled systemic disease that, in the opinion of the Investigator, wouldpreclude participation in the study (eg, infection, uncontrolled elevated bloodpressure, cardiovascular disease, poor glycemic control) or put the subject at riskdue to study treatment or procedures
- Has had a myocardial infarction, other acute cardiac event requiring hospitalization,stroke, transient ischemic attack, or treatment for acute congestive heart failurewithin 1 month before enrollment
Study Design
Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Eylea
Phase: 4
Study Start date:
June 11, 2019
Estimated Completion Date:
October 27, 2022
Study Description
Connect with a study center
Texas Retina Associates
Dallas, Texas 75231
United StatesSite Not Available
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