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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    50
  • sponsor
    The Cleveland Clinic
Updated on 31 July 2021
angiography
dexamethasone
retinopathy
diabetic retinopathy
corrected visual acuity
visual impairment
aflibercept
edema secondary
retinal edema

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.

Details
Condition Diabetic Macular Edema
Treatment Aflibercept, Dexamethasone implant
Clinical Study IdentifierNCT04411693
SponsorThe Cleveland Clinic
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Any history of severe allergy to fluorescein sodium (e.g., anaphylaxis, difficulty breathing) or other reason that the patient is unable to undergo fluorescein angiography (e.g., inability to get vascular access, unable to tolerate procedure). If allergy is mild and investigator believes can be pretreated with diphenhydramine to avoid allergic response, this is not an exclusion to enrollment
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
Any history of macular hole of stage 2 and above in the study eye
Any intraocular or periocular surgery within 3 months of Day 1 in the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection
Prior trabeculectomy or other filtration surgery in the study eye
Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye
Any history of uveitis in either eye
Active scleritis or episcleritis in either eye
Presence or history of scleromalacia in either eye
Aphakia in the study eye
Previous therapeutic radiation in the region of the study eye
History of corneal transplant or corneal dystrophy in the study eye
Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography
Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the study period
Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety
Participation as a subject in any clinical study within the 12 weeks prior to Day 1
Any systemic therapy with an investigational agent in the past 3 months prior to Day 1\
Any history of allergy to povidone iodine
Pregnant or breast-feeding women
Women of childbearing potential who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly) Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation
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