Clinical trial NCT03984110: One Year Trial Evaluating Safety of Ozurdex With Eylea
Official title: The Use of a Combination of Ozurdex and Eylea Versus Eylea Monotherapy for Diabetic Macular Edema: A Prospective, Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Texas Retina Associates
Sponsor class: OTHER
Collaborators: name: The Emmes Company, LLC
First posted: 2019-06-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One Year Trial Evaluating Safety of Ozurdex With Eylea (COED)

Detailed description: In this study, the investigators aim to compare the effects of combined use of intravitreal injections of Ozurdex every three3 months and monthly Eylea/aflibercept to monthly intravitreal injections of aflibercept alone as measured by improvement in central subfield thickness from baseline at Week 48 in eyes with center-involving Diabetic Macular Edema and best-corrected visual acuity of 20/40 or worse

Eligibility criteria: Inclusion Criteria:

1. Type 1 or 2 diabetic patients
2. At least 18 years of age, understands the language of the informed consent, and is willing and able to provide written informed consent before any study procedures
3. 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 is not likely to permit dislocation of Ozurdex implant into the anterior chamber
4. Center-involving DME \> 300 µm
5. Baseline BCVA between 20/40 - 20/320
6. Eyes with intraocular pressure (IOP) ≤ 21 and / or treatment with \< 2 topical IOP-lowering medications (eyes with history of previous angle -closure or similar conditions that have been successfully treated with either laser or surgical intervention are allowed as long as the visual fields and optic nerves have been stable for \> 1 year prior to study entry and the patient has been and can be safely dilated)

Exclusion Criteria:

1. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
2. Patients with known hypersensitivity to any components of Eylea or Ozurdex
3. Patient has suffered from a stroke or transient ischemic attack (TIA) in the last 6 months
4. Patients using topical anti-inflammatory medication for the duration of the study
5. Patients with Anterior Chamber Intraocular Lens (ACIOL) and rupture of the posterior lens capsule
6. Prior panretinal photocoagulation or macular laser treatments within 90 days of screening
7. Previous vitrectomy
8. Any ocular condition that in the opinion of the investigator would not permit improvement of visual acuity with resolution of DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates and/or poor foveal architecture suggestive of photoreceptor loss)
9. Patients with retinal diseases other than diabetes that can affect macular edema
10. Eyes with a history of advanced glaucoma (optic nerve head change consistent with glaucoma damage and/or glaucomatous visual field loss), uncontrolled ocular hypertension (baseline IOP \> 21 mmHg despite use of ≥ 2 topical IOP-lowering medication)
11. Eyes with a history of steroid response (i.e., increase of ≥ 5 mmHg IOP following topical steroid treatment)
12. Female patients who are pregnant or breastfeeding
13. Patients who are unable to attend scheduled follow-up visits throughout the 24-week study
14. Any intravitreal anti-Vascular Endothelial Growth Factor (VEGF) treatment to study eye within 3 months prior to Day 1
15. Use of systemic steroid, anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment or anticipated use during the study (these drugs are prohibited from use during the study)
16. History of any previous treatment in the study eye with an ocular corticosteroid implant (eg Iluvien, Ozurdex, Retisert)
17. Has scarring from laser photocoagulation in the study eye that would compromise Visual Acuity (VA); or scarring or abnormality from other macular condition, in the investigator's medical judgement, would limit VA (such as an epiretinal membrane or macular hole)
18. Has significant media opacity precluding evaluation of retina and vitreous in the study eye. This includes cataract that is felt to be a major contributor to reduced visual acuity and/or likely to undergo surgical repair within 3 months of randomization.
19. Has any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study (eg, infection, uncontrolled elevated blood pressure, cardiovascular disease, poor glycemic control) or put the subject at risk due to study treatment or procedures
20. Has had a myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 1 month before enrollment

Primary outcomes:
measure: Central Subfield Thickness (CST)
timeFrame: 48 weeks
Secondary outcomes:
measure: CST
timeFrame: 12 weeks, 24 weeks, and 36 weeks
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: 12 weeks, 24 weeks, 36 weeks, and 48 weeks
measure: Number of additional Intravitreal Therapy (IVT) aflibercept injections required over 48 weeks
timeFrame: 48 weeks
measure: Monthly mean changes from baseline in BCVA
timeFrame: 48 weeks
measure: Monthly mean changes from baseline in CST
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
Study officials:
affiliation: Texas Retina Associates
name: Ashkan M Abbey, MD
role: PRINCIPAL_INVESTIGATOR
References: