DROPROP - a Randomized Interventional Multi-Center Study with the aim to investigate if Dexamethasone topical eye drops reduces the risk for proliferative retinopathy of prematurity needing treatment

Retinopathy of prematurity (ROP) affects preterm infants and can lead to retinal detachment and blindness. Of infants with proliferative ROP, 50% will need treatment with laser or anti-VEGF. In Sweden 40 infants are treated yearly.

Dexamethasone is a synthetic glucocorticoid commonly used on the ocular surface to treat inflammation and neovascularisation.

If treatment with dexamethasone eye drops is efficient in reducing proliferative ROP, thus preventing the need for other ROP treatment, infants may escape general anaesthesia, retinal laser destruction and intraocular injections. General anaesthesia is associated with worse neurodevelopmental outcome.

Laser therapy destroys parts of the retina and anti-VEGF enters the blood and suppresses VEGF with unknown longterm effects.

To reduce neovascularisation and inflammation in ROP, dexamethasone eye drops have been given off-label to infants with proliferative ROP in Lund, Skåne University Hospital, 2020.

Only 1% of all screened infants needed other ROP treatment after dexamethasone eye drops, compared to historical controls of whom 6% had been treated with laser or anti-VEGF yearly.We will perform a randomised, controlled, multicentre trial called DROPROP where preterm infants with proliferative ROP will recieve eye drops with dexamethasone or placebo for up to 6 weeks.

We aim to investigate whether treatment with dexamethasone eye drops reduces the proportion of infants needing laser therapy or anti-VEGF treatment for ROP.