- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067856
Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery
February 17, 2021 updated by: Pradeep Prasad, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bevacizumab
Intravitreal injection of 1.25mg/0.05cc
bevacizumab
|
Intravitreal injection
Other Names:
|
Active Comparator: Dexamethasone implant
Intravitreal injection of 0.7mg dexamethasone implant
|
Intravitreal injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Final visual acuity
Time Frame: 6 month
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Final optical coherence tomography central macular thickness
Time Frame: 6 month
|
6 month
|
Total number of intravitreal injections over study period
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
January 31, 2021
Study Completion (Actual)
January 31, 2021
Study Registration Dates
First Submitted
August 22, 2019
First Submitted That Met QC Criteria
August 22, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
February 21, 2021
Last Update Submitted That Met QC Criteria
February 17, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Lens Diseases
- Macular Edema
- Cataract
- Edema
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dexamethasone
- Bevacizumab
Other Study ID Numbers
- 22361-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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