Ozurdex for Edema

3
Effectiveness
3
Safety
Bay Area Retina Associates, Walnut Creek, CA
+3 More
Ozurdex - Drug
Eligibility
18+
All Sexes
Eligible conditions
Edema

Study Summary

This study is evaluating whether a drug which is used to treat macular edema may help reduce the risk of developing macular edema following cataract surgery.

See full description

Eligible Conditions

  • Edema
  • Cataract
  • Macular Edema
  • Diabetic Macular Edema (DME)

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Ozurdex will improve 1 primary outcome and 1 secondary outcome in patients with Edema. Measurement will happen over the course of 3 months after cataract surgery.

Month 3
Comparison of central foveal thickness outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy
Visual acuity outcomes of anti-vascular endothelial growth factor vs. Ozurdex therapy

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Side Effects for

Bevacizumab
vitreous hemorrhage
22%
worsening of cataract
17%
vitreous syneresis
9%
posterior capsule opacification
9%
pyelonephritis
4%
pneumonia
4%
colon cancer
4%
cranial nerve VI palsy
4%
bradycardia
4%
increased intraocular pressure
0%
epiretinal membrane
0%
congestive heart failure
0%
choroidal detachment
0%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02036424) in the Bevacizumab ARM group. Side effects include: vitreous hemorrhage with 22%, worsening of cataract with 17%, vitreous syneresis with 9%, posterior capsule opacification with 9%, pyelonephritis with 4%.

Trial Design

2 Treatment Groups

Anti-vascular endothelial growth factor
Ozurdex

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ozurdex is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Ozurdex
Drug
Intravitreal Ozurdex
Anti-vascular endothelial growth factorIntravitreal Bevacizumab, Ranibizumab, or Aflibercept
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months after cataract surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 months after cataract surgery for reporting.

Who is running the study

Principal Investigator
C. L.
Caesar Luo,, MD
Bay Area Retina Associates

Closest Location

Bay Area Retina Associates - Walnut Creek, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age > 18 years of age
Gender- All
Race- All
Diagnosis of Diabetes (Type 1 or 2) with a concomitant diagnosis of diabetic macular edema as demonstrated on spectral domain optical coherence tomography (Heidelberg Spectralis)
>250 microns central foveal thickness
Able and willing to provide informed consent

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can edema be cured?

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Despite an increase in edema, a positive clinical trial implies that edema itself is not necessarily benign. This change may signify active inflammation present in edema or may reflect the action of therapy for other, concurrent factors.

Unverified Answer

What are common treatments for edema?

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This review indicates that a variety of treatments for edema exist, such as compressions and nonsteroidal anti-inflammatory drugs (NSAIDs), topical medications, exercises, and surgery. Physicians can inform patients about these possible treatments by asking specific questions and making medical records transparent.

Unverified Answer

What is edema?

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Edema should be suspected in patients over the age of 55 years presenting with a loss of weight and fatigue, especially for those over 20 kg. It is also caused by overloading and by the inability to absorb vitamins, minerals and electrolytes in diet. It can be an indicator of systemic illness. The diagnosis of edema is most commonly made by the exclusion of other causes of loss of weight and fatigue. Once diagnosed, Edema can be treated by replacing or lowering salts, improving fluid retention and correcting the electrolytes. It can sometimes be treated by reducing physical activity, though the long term use of medications is advised over this option.

Unverified Answer

How many people get edema a year in the United States?

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Edema of the legs is a very common and treatable condition affecting up to 6.7% of patients with chronic cardiovascular disease. The U.S. Bureau of Labor Statistics reported the incidence of edema as 28,000 new cases of swelling due to the legs for every 100,000 in 1995. The estimated annual annual mean incidence for edema of the legs in the US is 8 per 100,000 persons. Because more than one-third of edema patients develop peripheral edema, the number of new patients with edema of the legs in the US may be even higher. The annual cost of treatments for peripheral edema and its many complications is over $1 billion.

Unverified Answer

What are the signs of edema?

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edema in the knee is a common symptom in adults and may be a leading factor in the development of acute knee pain in adolescents. The presence of edema and the presence of signs associated with edema on physical examination are important factors that should be considered when investigating patients with acute knee pain. The diagnosis of knee edema is made by the combination of a patient history and physical examination. Imaging of the knee and MR arthrography are both useful for evaluating knee edema.

Unverified Answer

What causes edema?

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Edema is a condition that causes swelling of the body. The blood vessels are blocked, causing fluid to accumulate on the extremities and the abdomen. Different areas in the body have different amounts of edema. The condition needs to be treated promptly, since it can affect heart function and cause high blood pressure. In some conditions edema causes complications to the heart that will need to be treated as well.

Unverified Answer

How does ozurdex work?

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[A study from the year 2000 looked at a sample of patients with breast edema and found that ozurdex (used in conjunction with steroid tablets) reduced the edema by an average of 21.3% over 30 weeks.] The only side effect that can be reported is that some patients experiencing lower blood pressure can become unwell during treatment; to get the lowest side effect while getting the best results, it is recommended to begin treatment while patients are not standing up, for example, when sleeping or taking a nap during the day. This way their blood pressure will not be affected; it would be normal to take your blood pressure every day and if it becomes low or higher, tell your doctor immediately.

Unverified Answer

Have there been any new discoveries for treating edema?

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There is little evidence supporting the use of diuretics or ACE inhibitors for treating edema in CKD patients. ACE inhibitors were not found to confer any significant survival benefit in this population. Further trials should focus on the development of ACE inhibitors for edema.

Unverified Answer

Does edema run in families?

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The observed increased risk was the same in both sexes, indicating that the trait is familial; however, there was no specific locus on chromosome 7. Data from a recent study suggests that there are at least 2 genes which regulate the etiology of edema.

Unverified Answer

What is the latest research for edema?

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A Cochrane review found limited evidence to support the use of a number of home-based, manual compression, and transcutaneous electric nerve stimulation for edema. No evidence was found for the use of transcutaneous electrical nerve stimulation and manual compressions for edema. More than a quarter of the research reviewed was of low methodological quality, and there was no evidence of any benefit of these interventions for edema.

Unverified Answer

What does ozurdex usually treat?

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Although it is most common to treat edema with ozurdex, it should be considered for other indications as well, and patients should never be assured that ozurdex will be a cure for their edema. The most frequent indications for ozurdex were pruritus, chronic itchy skin, and relief of lymphedema.

Unverified Answer

Is ozurdex typically used in combination with any other treatments?

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Ozurdex is generally used in combination with other treatments such as [lumpectomy (removing a malignant tumor-causing abnormal growth in the breast), radiotherapy, chemotherapy treatments, and more than half patients received some kind of anti-inflammatory medication.

Unverified Answer
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