One Year Trial Evaluating Safety of Ozurdex With Eylea

NCT ID: NCT03984110

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-11
• Study Completion Date: 2022-10-27

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

Conditions

Diabetic Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination of Ozurdex and Eylea

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

Group Type: EXPERIMENTAL

Ozurdex

Intervention Type: DRUG

Intravitreal injection

Eylea

Intervention Type: DRUG

Intravitreal injection

Eylea Monotherapy

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

Group Type: ACTIVE_COMPARATOR

Eylea

Intervention Type: DRUG

Intravitreal injection

Interventions

Ozurdex

Intravitreal injection

Intervention Type: DRUG

Eylea

Intravitreal injection

Intervention Type: DRUG

Other Intervention Names

dexamethasone implant; aflibercept

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

Texas Retina Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashkan M Abbey, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Retina Associates

Locations

Texas Retina Associates

Dallas, Texas, United States

Countries

United States

Other Identifiers

TRA-COED-19-001

Identifier Type: -

Identifier Source: org_study_id