Cataract Clinical Trial
Official title:
Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
The purpose of this research is to compare the effectiveness of bevacizumab (Avastin) with another a dexamethasone implant (Ozurdex), with respect to anatomic and visual outcomes as well as injection frequency in subjects undergoing cataract surgery with a concurrent diagnosis of diabetic macular edema (DME).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 31, 2021 |
Est. primary completion date | January 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Age greater than 18 years old with type one or type two diabetes mellitus - Center-involving diabetic macular edema with central subfield thickness = 320um on Heidelberg Spectralis optical coherence tomography (OCT) testing - Best-corrected electron-early treatment diabetic retinopathy study (E-ETDRS Visual Acuity) visual acuity letter score between 78 to 24 - Any Lens Opacities Classification System (LOCS) III cataract grade greater than or equal to two Exclusion Criteria: - Presence of macular edema attributable to other causes including but not limited to retinal venous occlusive disease and non-infectious uveitis - History of glaucoma - History of steroid-induced intraocular pressure (IOP) elevation that required IOP-lowering treatment - Optic nerve cup to disc ratio greater than 0.6 - Active proliferative diabetic retinopathy - Presence of other retinal diseases including but not limited to age-related macular degeneration, retinal venous occlusive disease and posterior segment uveitis - Any prior intraocular surgery - Treatment with any anti-VEGF medication within the past 3 months or intravitreal steroid within the past 6 months - Panretinal photocoagulation within the prior 6 months or anticipated need for panretinal photocoagulation within the next 6 months - IOP greater than or equal to 25 - Systolic blood pressure > 180 mmHg or diastolic > 110 mmHg - Myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack or treatment for acute congestive heart failure within the past 6 months |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Allergan, Doheny Image Reading Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Final visual acuity | 6 month | ||
Secondary | Final optical coherence tomography central macular thickness | 6 month | ||
Secondary | Total number of intravitreal injections over study period | 6 month |
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