Status:
WITHDRAWN
Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsors:
Allergan
Doheny Image Reading Center
Conditions:
Diabetic Macular Edema
Cataract
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Subjects over the age of 18 with both: 1) visually significant cataracts requiring cataract surgery and 2) diabetic macular edema (DME) will be enrolled in the study. Subjects with high risk prolifera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04067856
Start Date
January 1 2020
End Date
January 31 2021
Last Update
February 21 2021
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