One Year Trial Evaluating Safety of Ozurdex With Eylea

NCT03984110 | Completed Phase 4 FDA Drug

• 1 other identifier: TRA-COED-19-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Central Subfield Thickness (CST)

  Change in Central Subfield Thickness (CST) on Spectral Domain-Optical Coherence Tomography (SD-OCT)

  48 weeks

Secondary Outcomes (5)

• CST

  12 weeks, 24 weeks, and 36 weeks

• Best Corrected Visual Acuity (BCVA)

  12 weeks, 24 weeks, 36 weeks, and 48 weeks

• Number of additional Intravitreal Therapy (IVT) aflibercept injections required over 48 weeks

  48 weeks

• Monthly mean changes from baseline in BCVA

  48 weeks

• Monthly mean changes from baseline in CST

  48 weeks

Study Arms (2)

Combination of Ozurdex and Eylea

EXPERIMENTAL

Eyes receiving intravitreal injection of Ozurdex every 3 months (as needed per protocol) and intravitreal injection of Eylea every month (as needed per protocol)

Drug: Ozurdex; Drug: Eylea

Eylea Monotherapy

ACTIVE COMPARATOR

Eyes receiving intravitreal injection of Eylea every month (as needed per protocol)

Drug: Eylea

Interventions

Ozurdex DRUG

Intravitreal injection

Also known as: dexamethasone implant

Combination of Ozurdex and Eylea

Eylea DRUG

Intravitreal injection

Also known as: aflibercept

Combination of Ozurdex and Eylea; Eylea Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or 2 diabetic patients
• 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
• 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
• Center-involving DME \> 300 µm
• Baseline BCVA between 20/40 - 20/320
• 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)

You may not qualify if:

• 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.
• 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 6 months
• Patients using topical anti-inflammatory medication for the duration of the study
• Patients with Anterior Chamber Intraocular Lens (ACIOL) and rupture of the posterior lens capsule
• Prior panretinal photocoagulation or macular laser treatments within 90 days of screening
• Previous vitrectomy
• 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)
• Patients with retinal diseases other than diabetes that can affect macular edema
• 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)
• Eyes with a history of steroid response (i.e., increase of ≥ 5 mmHg IOP following topical steroid treatment)
• Female patients who are pregnant or breastfeeding
• Patients who are unable to attend scheduled follow-up visits throughout the 24-week study
• Any intravitreal anti-Vascular Endothelial Growth Factor (VEGF) treatment to study eye within 3 months prior to Day 1
• 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)

Sponsors & Collaborators

• Texas Retina Associates: lead
• The Emmes Company, LLC: collaborator

Study Sites (1)

Texas Retina Associates

Dallas, Texas, 75231, United States

Location

MeSH Terms

Interventions

Calcium Dobesilate; Dexamethasone; aflibercept

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ashkan M Abbey, MD

  Texas Retina Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 12, 2019
• Study Start: June 11, 2019
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)