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

NCT02036424 | Completed Phase 4 Results DMC

• 1 other identifier: OA 003
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline to month 7

• 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.

  baseline to month seven

Study Arms (2)

Bevacizumab

ACTIVE COMPARATOR

1.25 mg intravitreal injection given monthly during a 6 month period

Drug: Bevacizumab

Ozurdex

ACTIVE COMPARATOR

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

Drug: Ozurdex

Interventions

Ozurdex DRUG

intravitreal steroid

Also known as: Dexamethasone Intravitreal Implant

Ozurdex

Bevacizumab DRUG

antiVEGF

Also known as: Avastin

Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raj K. Maturi, MD: lead
• Allergan: collaborator

Study Sites (1)

Raj K Maturi MD PC

Indianapolis, Indiana, 46290, United States

Location

MeSH Terms

Interventions

Calcium Dobesilate; Dexamethasone; Bevacizumab

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Raj K. Maturi, MD
• Organization: Raj K. Maturi, MD, PC

rmaturi@gmail.com

317-817-1414

Study Officials

• Raj K Maturi, MD

  Raj K. Maturi, MD, PC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Raj K. Maturi MD, PI

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 15, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 1, 2015
• Results First Posted: November 3, 2015

Record last verified: 2015-11

Locations

US (1)