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CompletedNCT02036424Updated Dec 1, 2015Results posted

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

A Phase 4 interventional study of Ozurdex and Bevacizumab in Diabetic Macular Edema, sponsored by Raj K. Maturi, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-12-01.

Sponsored by Raj K. Maturi, MD · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Diabetic Macular Edema
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 45 is close to the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

This is the only study on the registry with Raj K. Maturi, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Bevacizumab

    1.25 mg intravitreal injection given monthly during a 6 month period

    Drug: Bevacizumab

  • Active comparator
    Ozurdex

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

    Drug: Ozurdex

Interventions

  • DrugOzurdex

    intravitreal steroid

    Also known as: Dexamethasone Intravitreal Implant

  • DrugBevacizumab

    antiVEGF

    Also known as: Avastin

06

What researchers measure

Primary outcomes

  1. Mean Visual Acuity Change

    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.

    Time frame: baseline to month 7

  2. Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From 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.

    Time frame: baseline to month seven

07

Results

Posted Nov 3, 2015

Participant flow

Subjects were recruited from the PI's clinical practice from January 2014 through October 2014.

Participant flow — Overall Study
MilestoneBevacizumabOzurdex
Started2327
Completed2327
Not completed00

Outcome measures

PrimaryMean Visual Acuity Change

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.

Time frame:
baseline to month 7
Reported as:
Mean · ETDRS letters
Mean Visual Acuity Change
ETDRS lettersBevacizumabOzurdex
Mean Visual Acuity Change5.6 ± 6.15.8 ± 7.6
PrimaryChange in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From 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.

Time frame:
baseline to month seven
Reported as:
Mean · microns
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
micronsBevacizumabOzurdex
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven-13 ± 105-122 ± 120

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bevacizumab—7/23 (30.4%)10/23 (43.5%)
Ozurdex—3/22 (13.6%)15/27 (55.6%)
Most frequent serious events
Most frequent serious events
EventBevacizumabOzurdex
vitreous hemorrhageEye disorders2/231/22
choroidal detachmentEye disorders0/231/22
congestive heart failureCardiac disorders0/231/22
cranial nerve VI palsyEye disorders1/230/22
bradycardiaCardiac disorders1/230/22
pneumoniaRespiratory, thoracic and mediastinal disorders1/230/22
pyelonephritisRenal and urinary disorders1/230/22
colon cancerGastrointestinal disorders1/230/22
Most frequent other events
Most frequent other events
EventBevacizumabOzurdex
increased intraocular pressureEye disorders0/2314/27
worsening of cataractEye disorders4/237/27
vitreous hemorrhageEye disorders5/232/27
posterior capsule opacificationEye disorders2/234/27
vitreous syneresisEye disorders2/233/27
epiretinal membraneEye disorders0/232/27

Baseline characteristics

23 and 27 reflect number of study eyes in each arm rather than number of subjects

Age, Categorical
Age, Categorical(Participants)BevacizumabOzurdexTotal
<=18 years000
Between 18 and 65 years141125
>=65 years91625
Age, Continuous
Age, Continuous(years)BevacizumabOzurdexTotal
Mean61 ± 965 ± 1163 ± 10
Sex: Female, Male
Sex: Female, Male(Participants)BevacizumabOzurdexTotal
Female101525
Male131225
Region of Enrollment
Region of Enrollment(study eyes)BevacizumabOzurdexTotal
United States232750
08

Study locations

1 site
  • Raj K Maturi MD PC
    Indianapolis, Indiana 46290, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02036424
Lead sponsor
Raj K. Maturi, MD
Collaborators
Allergan
Responsible party
Raj K. Maturi, MD (Raj K. Maturi MD, PI, Maturi, Raj K., M.D., P.C.) — Sponsor-investigator
First posted
Jan 15, 2014
Start date
Jan 2014
Primary completion
Aug 2015
Completion
Aug 2015
Results posted
Nov 3, 2015
Last update
Dec 1, 2015

Study contacts

Raj K Maturi, MD
principal investigator · Raj K. Maturi, MD, PC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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