Overview

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

Status:
Completed

Trial end date:
2015-08-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Raj K. Maturi, MD

Collaborator:

Allergan

Treatments:

BB 1101
Bevacizumab
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Endothelial Growth Factors

Criteria

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