Active not recruitingPHASE2INTERVENTIONAL

Bevacizumab Treatment For Type 1 ROP

This study is about a severe eye condition called Retinopathy of Prematurity (ROP) that can affect premature babies. This specific type (Type 1 ROP in Zone I) is very serious and can cause significant vision problems. Researchers are testing a medicine called bevacizumab to see if it can help. They are trying out two different low doses of this medicine (0.063mg and 0.25mg) to find out which works best. The main goals are to see how well the medicine fixes the problem with the blood vessels in the eye and if it's safe. It's hoped this research will lead to better treatment for these vulnerable babies.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Jaeb Center for Health Research

Enrolment target

Start

01 May 2022

Estimated completion

01 Jul 2027

Retinopathy of Prematurity

What is this study about?

Retinopathy of Prematurity (ROP) is an eye condition that can affect babies born too early. In premature babies, the blood vessels in their eyes sometimes don't develop properly. This can lead to serious vision problems, and in some cases, even blindness. This particular study focuses on the most severe form of ROP, called Type 1 ROP in Zone I, which carries the highest risk of vision loss. It's really important to find effective treatments for this specific type.

Doctors are looking at a medicine called bevacizumab, which is given as a very small injection directly into the eye. This medicine is already used for some eye conditions, but for ROP, researchers are still trying to understand the best dose to use. This study will compare two different low doses of bevacizumab (0.063mg and 0.25mg) to see which one works better and what happens to the tiny blood vessels in the eye afterwards. The aim is to help these blood vessels grow in a healthy way.

The idea is to improve how we treat this severe form of ROP. By finding the most effective and safest dose, doctors hope to protect the eyesight of these smallest and most vulnerable babies and give them the best possible start in life. This kind of research is vital for improving care for premature infants.

Key takeaways

This study focuses on a severe eye condition in premature babies called Type 1 ROP.
It's testing two different low doses of a medicine called bevacizumab.
The main goal is to find the best dose to help eye blood vessels grow safely and prevent vision problems.
Your baby would have several eye check-ups over many months.
The study aims to improve future treatments for babies with this serious condition.

Who may be eligible?

To join this study, a baby must meet certain requirements. They need to have been born weighing less than 1251 grams, which is about 2 pounds, 12 ounces. Also, they must have just been diagnosed (within the last two days) with Type 1 ROP in Zone I in at least one eye.

Babies would not be able to join the study if they've already had any treatment for ROP, or if their ROP is already very advanced (Stage 4 or 5). They also can't take part if the treatment couldn't be given within two days of diagnosis, or if they have an active eye infection. If the baby is expected to transfer to another hospital soon where they can't get special eye exams, or if the parents can't commit to follow-up visits, they also wouldn't be able to join.

Sometimes, if there's another eye problem like a cataract or something blocking the view of the retina in one eye, that eye might not be included, but the other eye could still be eligible for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Was your baby born weighing less than 1251 grams (about 2 pounds, 12 ounces)?
Has your baby just been diagnosed (in the last 2 days) with Type 1 ROP in Zone I?
Has your baby NOT had any ROP treatment before?
Does your baby NOT have very advanced ROP (Stage 4 or 5)?
Does your baby NOT have an active eye infection?

Answer every question to see your result.

What does participation involve?

If your baby joins this study, they will receive a small injection of bevacizumab into one or both eyes, depending on their condition. This medicine will be one of two different low doses, decided randomly, like flipping a coin. After the injection, your baby will have several eye exams: one day after, then four days after (if needed), and then weekly for four weeks. Further exams will happen at 2 and 4 months after the treatment.

There will also be check-ups at an adjusted age of 6 months and 12 months. Your baby might have other eye checks outside of the study, as decided by their doctor. The main goal is to see if the treatment works within the first four weeks, meaning the ROP improves and doesn't get worse. If needed, your baby might receive more treatment. The study also looks at how safe the treatment is, how well it helps their sight, and how the blood vessels in their eyes develop over time.

Potential risks and benefits

Taking part in this study could potentially benefit your baby's eyesight by offering a new approach to treating severe ROP, helping their eye develop more normally. However, as with any medical treatment, there are potential risks, side effects could occur from the injection itself or from the medicine, but these will be closely monitored. The full extent of how these lower doses might affect the eye long-term is still being studied. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (26)

Arkansas Childrens Hospital/ University of Arkansas Medical Sciences
Verified postcode
Little Rock, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Verified postcode
Irvine, United States
Jules Stein Eye Institute at the University of California, Los Angeles
Verified postcode
Los Angeles, United States
University of California, Davis
Verified postcode
Sacramento, United States
University of California San Francisco Department of Ophthalmology
Verified postcode
San Francisco, United States
The Emory Eye Center
Verified postcode
Atlanta, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Verified postcode
Chicago, United States
U of Illinois at Chicago Eye and Ear Infirmary
Verified postcode
Chicago, United States
University of Chicago
Verified postcode
Hyde Park, United States
Indiana University School of Medicine
Verified postcode
Indianapolis, United States
Riley Hospital for Children
Verified postcode
Indianapolis, United States
UK Ophthalmology and Visual Sciences, The Eye Clinic
Verified postcode
Lexington, United States

Common questions

What is ROP?

ROP (Retinopathy of Prematurity) is an eye condition that can affect premature babies, causing problems with how blood vessels grow in the eye.

What is bevacizumab?

Bevacizumab is a medicine that will be given as a tiny injection into the eye. It's being studied to help the blood vessels in babies' eyes grow healthily.

Why are there two different doses?

Researchers want to find out which of two low doses works best – 0.063mg or 0.25mg – to treat severe ROP and protect vision.

How long will my baby be in the study?

Your baby will have eye exams for several months after the treatment, including follow-ups at 6 and 12 months (adjusted age).

Can I take my baby out of the study if I change my mind?

Yes, you can choose to withdraw your baby from the study at any time, and it won't affect their medical care.