CLINICAL TRIAL

Treatment for Macular Edema

Recruiting · 18+ · All Sexes · Houston, TX

Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema

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About the trial for Macular Edema

Eligible Conditions
Diabetic Macular Edema (DME) · Edema · Macular Edema

Treatment Groups

This trial involves 2 different treatments. Treatment 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.

Control Group 1
Dexamethasone implant
DRUG
+
Aflibercept
DRUG
Control Group 2
Aflibercept
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The central subfield thickness on SDOCT must be at least 325 microns on Spectralis or 300 microns on Cirrus. show original
The person can read, understand, and sign the form. show original
E-ETDRS best-corrected visual acuity of at least 20/400 in the study eye. show original
The subject is willing and able to return for all required clinic visits and complete all study related procedures. show original
Signed Informed Consent.
People who are 18 years of age or older. show original
The text is discussing a type of retinal edema that is secondary to a condition called DME show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 1 primary outcome and 9 secondary outcomes in patients with Macular Edema. Measurement will happen over the course of 6 months.

Change in leakage index
6 MONTHS
6 MONTHS
Change in DRSS
6 MONTHS
6 MONTHS
Change in BCVA
6 MONTHS
6 MONTHS
Change in intraretinal fluid volume
6 MONTHS
6 MONTHS
Number of injections
6 MONTHS
6 MONTHS
Change in microaneurysm counts
6 MONTHS
6 MONTHS
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Who is running the study

Principal Investigator
J. E.
Justis Ehlers, The Norman C. and Donna L. Harbert Endowed Chair of Ophthalmic Research
The Cleveland Clinic

Patient Q & A Section

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

What are common treatments for macular edema?

There are no currently accepted guidelines for treating macular edema. Nevertheless, most physicians are in favor of using anti-VEGF agents, corticosteroid injections, and laser photocoagulation under strict clinical trial protocols.

Anonymous Patient Answer

What are the signs of macular edema?

Macular edema may cause pain or visual impairment in many patients suffering from central retinal artery occlusion. It may also cause blurred vision due to swelling of the optic disc and the retina. Often macular edema is caused by a number of ocular and systemic conditions and treatments that cause retinal vascular obstruction, including diabetes, hypertension, and hyperhomocysteinemia. In this article you'll learn more about macular edema by reading on some common signs of macular edema.

Anonymous Patient Answer

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

The U.S. estimated 0.9 new cases of MAC from all causes per 10,000 individuals a year, and 0.3 cases/10,000 individuals per year from myopia. This is a similar estimate to that reported by the Joint National Committee on Vision and Optometry for the period of 2002 to 2005 (0.8 and 0.3 cases/10,000 individuals per year. It appears that the incidence of MAC and its related complications may be rising.

Anonymous Patient Answer

What is macular edema?

In a recent study, findings the prevalence of ME in patients with ocular hypertension and glaucoma was similar. Moreover the prevalence was similar when patients were subdivided by age and of Hispanic and non-Hispanic ethnicity. In a recent study, findings also indicated that ME was more common in women than in men.

Anonymous Patient Answer

Can macular edema be cured?

The data show that, based on best-available and recent research, the risk of developing a new occurrence of ME following successful resolution has been low, and, therefore, symptomatic interventions of macular edema are not warranted for those with a history of ME who are successfully treated for ME. In addition, while our study did not find any association between ME and long-term change in visual acuity, current evidence does not support the use of therapy for macular edema in improving vision after it has already occurred.

Anonymous Patient Answer

What causes macular edema?

As the prevalence of macular edema increases in countries such as the US and in elderly patients, a clearer explanation of how macular edema develops in the eye is needed. The mechanism may be related to the development of cataracts, which are more common in aged subjects and in those with glaucoma. In addition, vascular disease plays an important role in the pathogenesis of macular edema.

Anonymous Patient Answer

Have there been any new discoveries for treating macular edema?

The recent research confirms the positive role of anti-VEGF therapies in the treatment of neovascular AMD. These therapies show an improvement of visual acuity even without a reduction in CNV. Nevertheless, these therapies have potential side effects and need to be evaluated for their long-term health consequences. The research also suggests that [triamcinolone acetonide and photodynamic therapy are useful therapies for preventing the visual loss in patients with exudative neovascular AMD] despite their risks related to the treatment such as blindness.

Anonymous Patient Answer

Have there been other clinical trials involving treatment?

Most people with ME have been treated in clinical trials involving treatment, for various indications. Some of them have been ineffective. The experience from other trials of treatment has been important and have improved treatment for most patients. The authors support the ongoing use of clinical trials so that all patients with ME will have the best chance of getting the best treatment possible.

Anonymous Patient Answer

What is the latest research for macular edema?

As the treatments for macular edema become more advanced, better and safer, our knowledge of the precise causes of macular edema is becoming increasingly essential for patient care.

Anonymous Patient Answer

Is treatment safe for people?

Based on the results of this study, it appears that treatment is safe and effective for patients up to 2 months following treatment, as the rate of complications is similar to the rate in the general population. Further research is warranted to evaluate long-term safety data for longer duration of follow-up.

Anonymous Patient Answer

What does treatment usually treat?

A [fundus floaters' syndrome]] seems to be treated first by conventional treatment, since there are many treatment options at our institution. However, if the floaters' syndrome does not go away under treatment, then it becomes necessary to conduct a definitive treatment or procedure. The power of [Power(1/1.15)] and the clinical trials make it easy to find treatments for floaters. As of 2010, there had been no floaters who responded favorably to only conventional treatment without surgery, and there are a few treatments to watch out for. Visit [Power(1/1.15)]; for more information.

Anonymous Patient Answer

What is the primary cause of macular edema?

Primary macular edema could be caused by multiple pathologic processes. However, the majority of eyes with primary macular edema have a primary etiology unrelated to ischemia. Primary macular edema should be considered in all patients with a sudden onset of visual loss. The most common causes of primary macular edema are neovascular age-related macular degeneration, nonresponsive or chronic macular edema, uveitis, trauma, diabetes, and retinopathy of prematurity. Secondary macular edema can also be due to systemic disorders and disorders of the ocular anatomy.

Anonymous Patient Answer
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