Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery

• Status: Withdrawn
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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 frequency in subjects undergoing cataract surgery with a concurrent diagnosis of diabetic macular edema (DME).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Collaborators: Allergan; Doheny Image Reading Center
• Treatments: BB 1101; Bevacizumab; Dexamethasone; Dexamethasone acetate

Criteria

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