Bevacizumab Treatment For Type 1 ROP

Launched by JAEB CENTER FOR HEALTH RESEARCH · Nov 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of low doses of a medication called bevacizumab for treating a serious eye condition known as type 1 retinopathy of prematurity (ROP) in premature infants. This particular type of ROP affects the most vulnerable part of the retina and can lead to severe vision problems if not treated promptly. The trial will compare two different low doses of bevacizumab (0.063 mg and 0.25 mg) to see if they can help improve the condition, especially in a specific area of the retina called zone I.

To participate in this study, infants must be born weighing less than 1251 grams and must be newly diagnosed with type 1 ROP in zone I within the last two days. Unfortunately, those who have already received treatment for ROP or have more advanced stages of the disease will not be eligible. If your child qualifies and you decide to participate, they will receive one of the study treatments and will be monitored closely to see how their eyes respond. This trial is currently recruiting participants, and it aims to provide more information about the best treatment options for this serious condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• The study participant must have at least one eye meeting all of the inclusion criteria in order to be eligible to participate:
• • 1. Birth weight \< 1251 grams
• • 2. Newly diagnosed (within 2 days) type 1 ROP in zone I in one or both eyes
• Exclusion Criteria:
• • Participants meeting any of the following exclusion criteria will be excluded from study participation.
• • 1. Previous treatment for ROP
• • 2. Stage 4 or 5 ROP in either eye
• • 3. Treatment could not be done within 2 days of diagnosis of type 1 ROP
• • 4. Investigator unwilling to randomize or parent unwilling to accept randomized assignment to either treatment
• • 5. Transfer to another hospital anticipated within the next 4 weeks where exams by study-certified examiners are not available. If hospital discharge is anticipated within the next 4 weeks, parents unable or unwilling to return to the PEDIG site for outpatient follow-up visits.
• • 6. Active ocular infection or purulent nasolacrimal duct obstruction in either eye
• One eye will be excluded, and other eye may be eligible, if either of the following are present:
• • Visually significant ocular anomaly (e.g., cataract, coloboma)
• • Opacity that precludes an adequate view of the retina