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
Overview
- Phase
- Phase 4
- Intervention
- Bevacizumab
- Conditions
- Diabetic Macular Edema
- Sponsor
- Raj K. Maturi, MD
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Mean Visual Acuity Change
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
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.
Investigators
Raj K. Maturi, MD
Raj K. Maturi MD, PI
Maturi, Raj K., M.D., P.C.
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Bevacizumab
1.25 mg intravitreal injection given monthly during a 6 month period
Intervention: Bevacizumab
Ozurdex
Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Intervention: Ozurdex
Outcomes
Primary Outcomes
Mean Visual Acuity Change
Time Frame: baseline to month 7
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.
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
Time Frame: 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.