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Completed

NCT Number: NCT02036424

Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Raj K Maturi MD PC

Indianapolis, Indiana, 46290, United States

About this study

Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male of female age 18 years or older
  • Type 1 or Type 2 diabetes
  • Best corrected visual acuity (BCVA) score of >24 and <78 letters
  • History of at least 3 anti-VEGF intravitreal injections over the past 5 months
  • Presence of macular edema defined as central subfield thickness of >340 microns on Cirrus OCT

Exclusion criteria

  • Anti-VEGF intravitreal treatment in the last 4 weeks
  • Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months
  • Pan retinal photocoagulation (PRP) or focal laser in the last 4 months
  • Active iris neovascularization
  • Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result
  • Uncontrolled systemic disease
  • Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications
  • Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit
  • Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception
  • Any condition or reason (including inability to read early treatment diabetic retinopathy study (ETDRS) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study
  • 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.
  • Aphakia or pseudophakia with anterior chamber intraocular lens
  • Hypersensitivity to any components of Ozurdex or Avastin

Treatment and study plan

Ozurdex

Drug

intravitreal steroid

Other names: Dexamethasone Intravitreal Implant

Bevacizumab

Drug

antiVEGF

Other names: Avastin

Primary outcomes

  1. Mean Visual Acuity Change

    Time frame: baseline to month 7

    Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.

  2. Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven

    Time frame: baseline to month seven

    Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.

Sponsors and collaborators

Lead sponsor

Raj K. Maturi, MD

Indiv

Collaborators

  • Allergan

Registry information

Official study title

A 10 Month, Single Masked, Randomized Controlled Study to Assess Anti-VEGF Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 15, 2014
Registry last updated
Dec 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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