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

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ClinicalTrials.gov Identifier: NCT04067856
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborators:
Allergan
Doheny Image Reading Center
Information provided by (Responsible Party):
Pradeep Prasad, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Cataract Drug: Bevacizumab Injection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

Arm Intervention/treatment
Active Comparator: Bevacizumab
Intravitreal injection of 1.25mg/0.05cc bevacizumab
Drug: Bevacizumab Injection
Intravitreal injection
Other Name: dexamethasone implant injection

Active Comparator: Dexamethasone implant
Intravitreal injection of 0.7mg dexamethasone implant
Drug: Bevacizumab Injection
Intravitreal injection
Other Name: dexamethasone implant injection




Primary Outcome Measures :
  1. Final visual acuity [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Final optical coherence tomography central macular thickness [ Time Frame: 6 month ]
  2. Total number of intravitreal injections over study period [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Pradeep Prasad, Assistant Clinical Professor of Ophthalmology, UCLA, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
ClinicalTrials.gov Identifier: NCT04067856    
Other Study ID Numbers: 22361-01
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cataract
Macular Edema
Edema
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Dexamethasone
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal