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

NCT ID: NCT04067856

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-01-31

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

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 proliferative diabetic retinopathy and any other retinal vascular disease or retinal pathology that may limit vision will be excluded. Baseline photography will be done to quantify the amount of DME and to exclude the presence of proliferative diabetic retinopathy or other retinal vascular or general retinal pathology. Subjects will be randomized to receive either an intravitreal injection of Ozurdex or Avastin at the time of cataract surgery. Subjects will be monitored the day after surgery, one to two weeks after cataract surgery and again monthly thereafter for a total of six visits from the time of cataract surgery with standardized visual acuity measurement, ophthalmologic examination and retinal photography performed at each visit. For the first two months after cataract surgery, subjects receiving Ozurdex will receive an injection of Avastin if the degree of swelling worsens by more than 10% on photography or the vision decreases. For the first two months after cataract surgery, subjects receiving Avastin will receive repeat injections of Avastin on a monthly basis. For each monthly visit thereafter, both groups will receive an intravitreal injection of Avastin if clinically significant DME is present or if vision declines.

Conditions

Diabetic Macular Edema; Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bevacizumab

Intravitreal injection of 1.25mg/0.05cc bevacizumab

Group Type: ACTIVE_COMPARATOR

Bevacizumab Injection

Intervention Type: DRUG

Intravitreal injection

Dexamethasone implant

Intravitreal injection of 0.7mg dexamethasone implant

Group Type: ACTIVE_COMPARATOR

Bevacizumab Injection

Intervention Type: DRUG

Intravitreal injection

Interventions

Bevacizumab Injection

Intravitreal injection

Intervention Type: DRUG

Other Intervention Names

dexamethasone implant injection

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

Doheny Image Reading Center

OTHER

Sponsor Role: collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Pradeep Prasad

Assistant Clinical Professor of Ophthalmology, UCLA

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

22361-01

Identifier Type: -

Identifier Source: org_study_id