Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema

NCT04411693 | Completed Phase 4 FDA Drug

• 1 other identifier: ALLER1908JE
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period. Subjects will be evaluated every month for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol. In addition, ultra-widefield angiography will be performed at run-in visit, baseline, month 3, and month 6.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• The mean change in central subfield thickness

  6 months

Secondary Outcomes (9)

• Number of injections

  6 months

• Change in BCVA

  6 months

• Change in leakage index

  6 months

• Change in ischemic index

  6 months

• Change in microaneurysm counts

  6 months

Study Arms (2)

Group A: Intravitreal Dexamethasone Implant

ACTIVE COMPARATOR

Subjects in this arm will be given intravitreal Dexamethasone implant injection at month 0. PRN intravitreal Dexamethasone implant injections will be given for persistent edema, if it has been 10 weeks or more since last implant injection. If it has been less than 10 weeks since last implant injection, subjects will receive PRN intravitreal Aflibercept for persistent edema.

Drug: Dexamethasone implant; Drug: Aflibercept

Group B: Intravitreal Aflibercept

ACTIVE COMPARATOR

Subjects in this arm will be given Intravitreal aflibercept at month 0. PRN intravitreal Aflibercept will be given at months 1-6 for persistent edema.

Drug: Aflibercept

Interventions

Dexamethasone implant DRUG

A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.

Also known as: Ozurdex

Group A: Intravitreal Dexamethasone Implant

Aflibercept DRUG

A single dose, 2mg, drug administered by intravitreal injection.

Also known as: Eylea

Group A: Intravitreal Dexamethasone Implant; Group B: Intravitreal Aflibercept

Eligibility Criteria

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

You may qualify if:

• Signed Informed Consent.
• Men and women ≥ 18 years of age.
• Foveal-involving retinal edema secondary to DME based on investigator review of SD-OCT.
• Central subfield thickness on SDOCT of greater than or equal to 325 microns on Spectralis or 300 microns on Cirrus.
• E-ETDRS best-corrected visual acuity of 20/400 or better in the study eye.
• Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
• Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

You may not qualify if:

• Any prior or concomitant therapy with another investigational agent to treat DME in the study eye.
• Prior panretinal photocoagulation in the study eye.
• Prior intravitreal anti-VEGF therapy in the study eye.
• Prior focal/grid laser photocoagulation in the study eye.
• Prior history of intravitreal steroid therapy in the study eye.
• Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye and/or cup-to-disc ratio greater or equal to 0.8.
• Active intraocular inflammation in either eye.
• Active ocular or periocular infection in either eye.
• Torn or ruptured posterior lens capsule in study eye. Laser capsulotomy is not a contraindication.
• Prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
• Significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam and ultra-widefield angiography, in study eye.
• Presence of other causes of macular edema, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal neovascularization, age-related macular degeneration or multifocal choroiditis in the study eye. Epiretinal membranes are allowed.
• Presence of macula-threatening traction retinal detachment in the study eye.
• Prior vitrectomy in the study eye.
• History of retinal detachment or treatment or surgery for retinal detachment in the study eye.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Allergan: collaborator

Study Sites (1)

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Dexamethasone; Calcium Dobesilate; aflibercept

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; 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: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Norman C. and Donna L. Harbert Endowed Chair of Ophthalmic Research

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 2, 2020
• Study Start: April 10, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)