Retinopathy of prematurity

An eye disease that can happen in babies born early or who weigh under about 3 pounds at birth. Abnormal blood vessels grow in the retina, the light-sensitive layer at the back of the eye. Some babies have mild disease that gets better without treatment; others need treatment to protect their sight. The National Eye Institute says there are no signs a parent can see, so babies at risk have a dilated eye exam a few weeks after birth.

Also called ROP

Condition
In this atlas

Overview

Technical summary

Condition page, from the NEI patient page (public domain). NEI gives the risk as birth before 30 weeks of pregnancy or weight under about 3 pounds, and the first exam as usually between 4 and 9 weeks after birth. Treatments it lists: observation for mild disease, laser treatment, injections of anti-VEGF medicines and eye surgery. The two trial pages (ETROP and the aflibercept record) carry the evidence. A 2018 policy statement on screening examination of premature infants was published in the journal Pediatrics; it is listed as an identity-only reference and its content was not read, so no screening schedule or criteria are recorded here. No incidence figure is recorded.

Recognition

NEI: there are no signs of ROP that a parent can see; at-risk babies are checked with a dilated eye exam.

Burden

No burden claims are published.

Claims and evidence

No claims are published for this condition yet.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Claim, not a settled fact Evaluated for this: Aflibercept (Evaluated for, seen from the other side)
Applies to Newborn
- 118 infants were randomised: gestational age 32 weeks or less at birth or birth weight 1500 g or less, with ROP of specified severity (zone I stage 1+, 2+, 3 or 3+, or zone II stage 2+ or 3+) needing treatment, or with aggressive posterior ROP, in at least one eye. 113 were treated and 104 completed the study. They were enrolled between September 25, 2019, and August 28, 2020, at 64 hospital sites in 27 countries across Asia, Europe and South America.
- 64 hospital sites in 27 countries throughout Asia, Europe and South America
- 27 countries across Asia, Europe and South America (the abstract names none)
- Infants with retinopathy of prematurity requiring treatment, with 24 weeks of follow-up
- Gestational age Not reported
- Postnatal age Not reported
Follow-up The primary outcome was treatment success 24 weeks after starting treatment: no active ROP and no unfavourable structural outcomes, assessed by investigators; the need for rescue treatment counted as treatment failure.
In FIREFLEYE, infants with retinopathy of prematurity needing treatment were randomised 2:1 to a 0.4-mg dose of intravitreal aflibercept (75 infants) or laser photocoagulation (43 infants randomised, 38 treated). Treatment success at 24 weeks was 85.5% with aflibercept and 82.1% with laser (between-group difference 3.4%; 1-sided 95% credible interval, -8.0% to infinity). Aflibercept was to be judged noninferior if the lower limit of that interval was above -5%; the authors report that it did not meet the criteria for noninferiority. Rescue treatment was needed in 4.8% of eyes in the aflibercept group and 11.1% in the laser group. Serious adverse events were 13.3% (ocular) and 24.0% (systemic) with aflibercept and 7.9% and 36.8% with laser. Three deaths, 4 to 9 weeks after aflibercept treatment, were considered unrelated to aflibercept by the investigators. The authors say further data are needed for more definitive conclusions. Separately, the US Eylea label lists retinopathy of prematurity among its five indications.
Limitations. Only the abstract was read. The abstract does not state whether the trial was masked; its primary outcome was assessed by investigators at 24 weeks. Noninferiority was not shown, so this record does not say aflibercept works as well as laser. The label lists the indication; the abstract and the label are separate sources, and the label wording does not rest on this trial in anything read here.
Claim, not a settled fact Treated by: Eylea (aflibercept) for retinopathy of prematurity (Claimed to treat, seen from the other side)
Applies to Newborn
- Patients with retinopathy of prematurity (ROP). ROP is one of five conditions the US label lists for treatment with Eylea: neovascular (wet) age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy and ROP. The indication list read gives no age or gestational limit for ROP; the label's dosing and clinical studies sections were not read.
- Not stated in the source
- United States (FDA-approved labelling)
- Patients with retinopathy of prematurity (a disease of babies born early, per the National Eye Institute)
- Gestational age Not reported
- Postnatal age Not reported
Follow-up Not applicable (regulatory context)
The US label for Eylea lists treatment of retinopathy of prematurity among its indications, and the FDA approval letter for supplement S-075 says the supplement provides for the addition of that indication.
Limitations. This is a regulatory statement: the label's indication list and the approval letter, not a trial result. The label's dosing and clinical studies sections were not read, so no outcome figure is recorded. FIREFLEYE, the trial abstract read for this atlas, did not meet its noninferiority criteria against laser; that result is a separate claim on the aflibercept page and does not support this one. Approval is not a recommendation for any baby.

Record details

Record id: maternal:retinopathy-of-prematurity
Content hash: ecaeb2c00e05a1c269131644b5aa6ad81f932e7a7a12a301120f1b220bddc471