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

NCT ID: NCT02036424

Last Updated: 2015-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bevacizumab

1.25 mg intravitreal injection given monthly during a 6 month period

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

antiVEGF

Ozurdex

Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections

Group Type ACTIVE_COMPARATOR

Ozurdex

Intervention Type DRUG

intravitreal steroid

Interventions

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Ozurdex

intravitreal steroid

Intervention Type DRUG

Bevacizumab

antiVEGF

Intervention Type DRUG

Other Intervention Names

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Dexamethasone Intravitreal Implant Avastin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Anti-VEGF intravitreal treatment in the last 4 weeks
2. Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months
3. Pan retinal photocoagulation (PRP) or focal laser in the last 4 months
4. Active iris neovascularization
5. Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result
6. Uncontrolled systemic disease
7. Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications
8. Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit
9. Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception
10. 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
11. 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.
12. Aphakia or pseudophakia with anterior chamber intraocular lens
13. Hypersensitivity to any components of Ozurdex or Avastin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Raj K. Maturi, MD

INDIV

Sponsor Role lead

Responsible Party

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Raj K. Maturi, MD

Raj K. Maturi MD, PI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Raj K Maturi, MD

Role: PRINCIPAL_INVESTIGATOR

Raj K. Maturi, MD, PC

Locations

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Raj K Maturi MD PC

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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OA 003

Identifier Type: -

Identifier Source: org_study_id