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
This trial is active, not recruiting.
|Condition||diabetic macular edema|
|Sponsor||Raj K. Maturi, MD|
|Start date||January 2014|
|End date||August 2015|
|Trial size||60 participants|
|Trial identifier||NCT02036424, OA 003|
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 OCT compared to the use of anti-VEGF alone.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Mean visual acuity change
time frame: baseline to month 7
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Male of female age 18 years or older 2. Type 1 or Type 2 diabetes 3. 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. 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 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 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
|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|
|Principal investigator||Raj K Maturi, MD|
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