Pediatric Ophthalmology Trials

Study Status: Enrolling

What is the purpose of this study?
The primary objective is to determine if infants with type 1 ROP treated with intravitreous bevacizumab have retinal treatment success rates that are noninferior to that of infants treated with laser photocoagulation.

Secondary objectives are to compare the number of re-treatments, extent of retinal vascularization, refractive error, visual acuity, visual fields, neurodevelopment, and systemic morbidities between treatment groups.

What will I have to do if I take part in this study?
If you decide to take part in this study, a computer program will be used to select whether your infant will be given bevacizumab or laser treatment.

If your infant is selected to start with bevacizumab, the injection will be performed by an eye surgeon and will be done through a small needle. If the ROP is worse or no better after the injection, then another injection will be done. The second injection will use a higher dose of bevacizumab. If the second treatment does not help your infant’s eye, then your eye surgeon may choose to use laser, bevacizumab, or both.

At about 6 months of age, if your infant’s blood vessels in the retina are still not growing normally, then your infant will receive laser treatment.

If your infant is selected to start with the laser, then your doctor will use the laser to treat the area of the retina that does not yet have any blood vessel growth. The treatment usually takes 20-45 minutes per eye. If the ROP is worse or no better after the laser, then another laser treatment may be done if there is space for more laser spots. If there is no space for more laser spots, then a bevacizumab injection will be done. If the second treatment does not help your infant’s eye, then your eye surgeon may choose to give more laser treatment, give a higher dose of bevacizumab, or both.

You will be asked to be in the study for about 6 years. Your infant will have eye exams. The exams are no more often than they would be if you do not join in the study. Pictures of the retina will be taken before treatment and one or two more times within the next several weeks. Pictures will be taken again at about age 6. These pictures take a few minutes and are not painful. If retinal pictures are not available at your site, then a 2nd eye exam will be done before treatment and later if the treatment is not successful.

At about 6 months of age, a motor development test called “General Movements Assessment” will be done. You will record and send a short video of your awake infant at home, and an expert will review the video and grade your infant’s movements. This recording will not be used for any other purpose.

At about two years of age, a developmental test will be done. This test takes about 60-90 minutes.

At about 6 years of age, a test of side vision will be done, which takes about 30 minutes. Also at about age 6, an IQ test and a visual-motor test will be done. These tests take about 60-90 minutes total. You will answer questions about life quality when your child is about one year old, and you and your child will complete them again when they are about 5 and 6 years old.

Is this the right trial for my child?
To take part in this study, your infant must:

• have severe ROP that requires treatment
• have a birth weight of less than 2 lb. 12.1 oz (or 1251 grams)
• live in North America
• be able to receive treatment in the next 2 days

Your infant must not:

• have had previous treatment for ROP
• have an active eye infection

For more information:

• Principal Investigator: Amy Hutchinson, MD
• Trial Coordinator: Olga Ostretsova
• ClinicalTrials.gov

Study Status: Enrolling

What is the purpose of this study?
The primary objective is to evaluate the safety of DEXYCU (dexamethasone intraocular injection) in the treatment of inflammation following ocular surgery for childhood cataract.

What will I have to do if I take part in this study?
Study duration will be approximately 3 to 4 months from Screening to the last. There will be 8 scheduled study visits. During the visit, the ophthalmic assessment will be processed by the investigator. All these procedures will be paid for by the study.

Is this the right trial for me?
The study is a trial in subjects 0 to 3 years of age who are undergoing ocular surgery for childhood cataract.

For additional information: 

• Principal Investigator: Phoebe Lenhart, MD
• Trial Coordinator: Ying Li  ying.li@emory.edu
• ClinicalTrials.gov: NCT05191706  Search Results | ClinicalTrials.gov