CLINICAL TRIAL

Bevacizumab for Retinal Diseases

Recruiting · < 18 · All Sexes · Atlanta, GA

This study is evaluating whether a drug may help improve vision for individuals with retinopathy of prematurity.

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About the trial for Retinal Diseases

Eligible Conditions
Retinopathy of Prematurity · Premature Birth · Retinal Diseases

Treatment Groups

This trial involves 2 different treatments. Bevacizumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Bevacizumab
DRUG
Experimental Group 2
Bevacizumab
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved

Side Effect Profile for Bevacizumab

Bevacizumab
Show all side effects
vitreous hemorrhage
22%
worsening of cataract
17%
vitreous syneresis
9%
posterior capsule opacification
9%
pneumonia
4%
pyelonephritis
4%
colon cancer
4%
cranial nerve VI palsy
4%
bradycardia
4%
epiretinal membrane
0%
increased intraocular pressure
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%, pneumonia with 4%.

Eligibility

This trial is for patients born any sex aged 18 and younger. You must have received newly diagnosed for Retinal Diseases or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The parent understands the procedure and is willing to consent to it. show original
If a baby's birth weight is less than 1251 grams, they are considered to be low birth weight show original
If both eyes are eligible, then both are included. If one eye is eligible and the other eye has type 1 ROP with ROP or vessels in zone 2, then both eyes will receive the treatment randomly assigned. If one eye is eligible and the fellow eye later develops type 1 ROP within 4 weeks of injection in the first eye, then the fellow eye will also receive the treatment randomly assigned to the first eye and the fellow eye will follow the same 4-week post-injection study exam schedule, unless the first eye has already met failure criteria, in which case treatment and follow-up for the fellow eye is at investigator discretion.
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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: 4 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4 weeks.
View detailed reporting requirements
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Bevacizumab will improve 1 primary outcome in patients with Retinal Diseases. Measurement will happen over the course of 4 weeks.

Treatment Success at 4 Weeks Post Injection
4 WEEKS
Treatment success, determined at 4 weeks, post injection, and meeting all the following criteria: Improvement by the 4-day exam (3 to 5 days) No recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks of injection.

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 retinal diseases?

Treatment of diabetic retinopathy depends on which stage of progression of the lesion the patient has, but all patients are encouraged to wear a new pair of eyeglasses after a certain amount of time. If a hole in the retina is present, it is important to fit the person with glasses with a concave base (called spectacles with the bifocal power lens. They have a reading lens and a distance lens. The reading lens is aimed to help in distance, and the reading lens helps the person see the chart clearly. Patients with severe diabetic retinopathy are encouraged to begin the process of corneal transplantation in order to prevent blindness by any late stages.

Anonymous Patient Answer

Can retinal diseases be cured?

In some cases, it is possible to eradicate blinding disease with specific therapy. However, even where treatment is not efficient, with certain diseases, even with no therapy, some people survive. In any case, long-term evolution varies from one case to another. Treatment should therefore be chosen according to the situation assessed in terms of prognosis and seriousness of disease.

Anonymous Patient Answer

What are the signs of retinal diseases?

The signs and symptoms of retinal diseases depend on the type and location of damage to the retina and the eye structure of the eye. Some common conditions can produce blurred vision and a variety of other symptoms. Most doctors have a reasonable history of retinal trauma or eye problems. For example, a family history of retinal problems may have indicated the need for additional tests.\n

Anonymous Patient Answer

How many people get retinal diseases a year in the United States?

Some 17 million Americans have a retinal illness each year. This represents about half of all people with retinal problems in the United States. For patients having an ophthalmic examination (optical diagnosis or treatment) or a refraction, about 10.4 million persons should receive a referral to an opthalmologist (ophthalmologist), and 1.0 million persons should receive a referral for a retinal examination. These patients would correspond to 9.7 million ophthalmologists, and 2.3 million retinal surgeons, in the United States.

Anonymous Patient Answer

What causes retinal diseases?

In our preliminary results of the study, retinal diseases were found to be much more common in people with coeliac disease than in the general population. We did not find any causal relationship between coeliac disease and retinal diseases. The study needs to be repeated as the results may change with more detailed analysis of the results of all types of studies with different populations of people.

Anonymous Patient Answer

What is retinal diseases?

Retinal diseases are a major source of vision loss in the industrialized world. Causes of disease vary widely but retinal diseases often result in chronic visual problems. Although retinal diseases affect many people, their impact can be mitigated by early detection and prevention along with appropriate treatment.

Anonymous Patient Answer

What is bevacizumab?

[A study was published confirming that bevacizumab inhibits angiogenesis in the retina. This inhibition may be associated with a reduction in retinal vaso-occlusive and vaso-reperfusion phenomena. In addition, it may alter vascular permeability, which may explain the reduction in neovascularization after a short-term follow-up in patients treated with bevacizumab, according to a previous report.] It may be worthwhile to study bevacizumab and other anti-angiogenic treatments in [age-related macular degeneration (AMD)] patients.

Anonymous Patient Answer

Does retinal diseases run in families?

Inherited retinal diseases occur more commonly in families with the same alleles for ocular disease gene loci than is the case for most non-ocular diseases. We discuss some causes for this finding and suggest that they may represent a clinically undetected form of linkage disequilibrium.

Anonymous Patient Answer

How serious can retinal diseases be?

With current tools, retinal disease progression can be measured and monitored, allowing early recognition and treatment. Future technologies hopefully will allow quantification of disease progress and will facilitate the development of strategies for earlier treatment.

Anonymous Patient Answer

What is the primary cause of retinal diseases?

In contrast to reports from North America, there was wide variation among European countries in the causative factors observed. We discuss the results in relation to differences in the social and economic circumstances and the way clinical cases are defined between nations. Results from a recent paper show the importance of further research on the incidence of uveitis in general eye disorders and on causal factors.

Anonymous Patient Answer

What is the average age someone gets retinal diseases?

It seems that the mean age that patients receive diagnosis of retinopathy and macular dystrophy is relatively low. Although our study is small, these results should be taken into consideration for the evaluation and treatment of diabetic and hypertensive retinopathies.

Anonymous Patient Answer

Is bevacizumab typically used in combination with any other treatments?

There is no evidence that any of the various therapeutic agents used in combination with Avastin are significantly better than Avastin alone. It is not possible to predict which drugs will be more effective in combination. It is, however, possible to predict which drugs might have a negative effect. In combination with Avastin, anti-VEGF agents (bevacizumab is the most commonly prescribed) should be avoided if available as they may compromise the effectiveness of Avastin.

Anonymous Patient Answer
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