A Study of Experimental Medicines Aflibercept vs. Bevacizumab for Diabetic Macular Edema (swelling in the center of the eye)

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Diabetic Macular Edema, macular edema
Type: Drug study, Phase 3
Target:
260 Participants
Investigator:
Description
Diabetic macular edema (DME) is the term used for swelling in the small central part of the retina. The retina is the light-sensitive tissue which lines the back of the eye. The macula or center part of the retina is used for sharp, straight-ahead vision. It is nourished by blood vessels that may become affected by diabetes. The blood vessels are weakened by become leaky. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can lead to decreased vision diabetes and may become leaky. This causes the retina to become thickened or swollen. Swelling of the central part of the retina can lead to decreased vision.

DME can be treated with repeated injections of drug into the eye to try to make the swelling of the retina go away. The drug is used to block or decrease a substance called vascular endothelia growth factor (it is an “anti-VEGF drug”). There are currently three different anti-VEGF drugs that are used as injections in eyes. However, only the following two, Avastin® and Eylea®, are being used in this study.

Avastin is approved by the Food and Drug Administration (FDA) for the treatment of cancer. It is not approved for treating DME. It needs to be specially prepared for injecting into the eye. However, studies have shown that Avastin injections can be beneficial for DME. Therefore, many doctors have been injecting it into the eye to treat DME.

Eylea is the other type of anti-VEGF drug being used in this study and was made for injection into the eye. It has been approved by the FDA for treatment of DME.

A recent survey of eye doctors estimated that about 60% of the injections in the U.S. for DME are given with Avastin, about 25% of the injections are given with Eylea, and about 15% with a third anti-VEGF drug called Lucentis®.
This study requires

The purpose of this study is to find out if starting with Eylea has better results than starting with the less expensive drug, Avastin, and only switching to Eylea if needed. If starting with Eylea is not better than starting with Avastin and switching to Eylea if needed, the potential cost savings to future patients and the health care system would be substantial. However, if starting with Eylea is better, then patients, clinicians, and health care providers can make informed decisions for how to best treat patients with DME and at least moderate vision loss.

If you agree to take part in the study, you will have a 50:50 chance of receiving Eylea from the start or receiving Avastin to start and switching to Eylea only if needed. If you start with Avastin, you initially will get an injection once a month for 3 months. At 3 months or anytime thereafter, if there has not been enough improvement in your vision and DME, you will be switched to Eylea. We expect about half of the eyes to switch to Eylea during the study. The entire study will last 2 years.

To summarize, both Eylea and Avastin have been shown to work for DME treatment. However, in patients with vision and DME like yours, Eylea has been shown to work better on average. It is possible that starting with Eylea will have similar results to starting with Avastin and switching to Eylea only if needed. By doing this study, we hope to be able to provide additional information for people with DME on how these two approaches compare.

Who can participate

To be eligible, the following inclusion criteria must be met:

  1. Age ≥ 18 years; Individuals <18 years old are not being included because DME is so rare in this age group that the diagnosis of DME may be questionable.
  2. Diagnosis of diabetes mellitus (type 1 or type 2); Any one of the following will be considered to be sufficient evidence that diabetes is present: Current regular use of insulin for the treatment of diabetes, Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes, Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions)
  3. At least one eye meets the study eye criteria listed in section
  4. Able and willing to provide informed consent.

An individual is not eligible if any of the following exclusion criteria are present:

  1. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). Individuals in poor glycemic control who, within the last four months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next four months should not be enrolled.
  3. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval for the indication being studied at the time of study entry. Note: study participants cannot receive another investigational drug while participating in the study.
  4. Known allergy to any component of the study drug or any drug used in the injection prep (including povidone iodine prep).
  5. Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible.
  6. Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study. These drugs cannot be used during the study
  7. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 24 months. Women who are potential study participants should be questioned about the potential for pregnancy. Investigator judgment is used to determine when a pregnancy test is needed.
  8. Individual is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the next two years.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you take part in the study, you will receive a $25 gift or money card for each visit required for the study.
Resources
Schedule
Study duration and period
The entire study will last about 2 years.
Recruitment period
From May 25, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Denise Macias
Research Topic
Conditions:
  • Diabetic Macular Edema

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