Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity (NCT05033106) | Clinical Trial Compass
UnknownPhase 3
Ranibizumab Vs Bevacizumab for Type 1 Retinopathy of Prematurity
Egypt36 participantsStarted 2020-09-01
Plain-language summary
Retinopathy of prematurity (ROP) with inadequate growth and development of retinal blood vessels in premature infants is one of the foremost reasons for childhood blindness. Recently there is a shift of treatment to VEGF inhibitors which can regress ROP without destroying the peripheral retina. Yet, the best drug has not been identified.Bevacizumab is a larger, full-length immunoglobulin G (IgG) molecule with slower retinal clearance and therefore prolonged diffusion into the systemic circulation, up to 3 weeks. In contrast, the systemic half-life of a Fab molecule, such as ranibizumab, is a few hours. The objective is to compare the efficacy and reliability of intravitreal bevacizumab with standard 0.625 mg dose and intravitreal ranibizumab treatments for type 1 ROP, namely pattern of disease regression, recurrence of ROP, necessity of subsequent ablative procedures.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\- Infants with a birth weight of ≤ 1500 g or geststional age of ≤ 30 weeks and selected infants with birth weight between 1500 and 2000 g or gestational age of more than 30 weeks with an unstable clinical course, including those requiring cardiorespiratory support. Patients with bilateral disease who will receive bilateral injections, are only included. Type 1 ROP according to ETROP study which is defined as, Zone I ROP with plus disease, Zone I, stage 3 ROP without plus disease and Zone II, stage 2 or 3 ROP with plus disease.
Exclusion Criteria:
Eyes with previous intravitreal injections. Eyes with previous laser therapy. Eyes with any other pathology, other than ROP. Eyes with ROP stage 4 or 5. Eyes with mucopurulent or purulent conjunctivitis. Infants who will not be able to comply to the follow-up schedule.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
• Regression achieved either by single injection or multiple injections or additional laser therapy at 60 weeks postmenstrual age.