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

Diabetic Macular Edema Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036424
• Other study ID #: OA 003
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2014
• Last updated: November 3, 2015
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Maturi, Raj K., M.D., P.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Ozurdex
intravitreal steroid
• Bevacizumab
antiVEGF

Locations

Country	Name	City	State
United States	Raj K Maturi MD PC	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Raj K. Maturi, MD	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes