Ozurdex in Suboptimal Diabetic Macular Edema Patients

NCT04856397 | Unknown

• 1 other identifier: 00001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary focus of this study is to understand the anatomic and visual outcomes of patients with refractory and suboptimal treatment response diabetic macular edema (DME) using anti-vascular endothelial growth factor (VEGF) to Ozurdex, an intravitreal dexamethasone implant. Secondly, investigators aim to understand the differences in cytokine profiles in patients who respond differently to intravitreal anti-VEGF versus Ozurdex. The importance of this study is to identify biomarkers that may help predict patients' response to different treatment protocols. Currently, Ozurdex is not covered by provincial health benefit plans for patients with DME. Our results may help improve access to care for those who have suboptimal results with or refractory to intravitreal anti-VEGF treatment.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  best corrected visual acuity (BCVA)

  1 year

Secondary Outcomes (5)

• OCT findings

  1 year

• OCTa findings

  1 year

• Cytokine expression TNFa

  1 year

• Cytokine expression IL-8

  1 year

• Cytokine expression IL-6

  1 year

Study Arms (4)

Control group

OTHER

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.

Drug: Eylea

Early switch

EXPERIMENTAL

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.

Drug: Intravitreal Implant in Applicator; Drug: Eylea

Late switch

EXPERIMENTAL

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

Drug: Intravitreal Implant in Applicator; Drug: Eylea

Non-switch

OTHER

Suboptimal responders who continue to receive monthly intravitreal anti-VEGF injections.

Drug: Eylea

Interventions

Intravitreal Implant in Applicator DRUG

Dexamethasone intravitreal implant

Also known as: Ozurdex

Early switch; Late switch

Eylea DRUG

anti-VEGF medication

Control group; Early switch; Late switch; Non-switch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Uptown Eye Specialists: lead

MeSH Terms

Interventions

Calcium Dobesilate; aflibercept

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are four cohorts of patients in this study (please see below on study procedures). To be able to have meaningful data showing statistical significance, we will need at least 30 patients in each cohort of patients, accounting for There will be at least 30 patients in each cohort. We will need at least 100 patients enrolled in the study prior to randomization of the non-responders into early switch (\~30) or late switch (\~30) or non-switch (\~30). The estimated number also accounts for the estimated number of patients who will be lost to follow-up or may drop out.

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: April 23, 2021
• Study Start: May 25, 2021
• Primary Completion: August 30, 2021
• Study Completion: December 29, 2021
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share