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Evaluation of timed dexamethasone eye drops to prevent proliferative retinopathy of prematurity: a study protocol for
Ann Hellström1,2, Mariya Petrishka-Lozenska3,4, Aldina Pivodic3,4
1The Sahlgrenska Centre for Pediatric Ophthalmology Research, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden. ann.hellstrom@medfak.gu.se.
Insights
Dexamethasone eye drops may prevent severe retinopathy of prematurity (ROP) from progressing to Type 1 ROP, reducing the need for laser or anti-VEGF treatments in preterm infants. This study assesses the efficacy and safety of this intervention.
Area of Science:
- Ophthalmology
- Neonatology
- Pharmacology
Background:
- Rising survival rates of preterm infants increase the risk of sight-threatening retinopathy of prematurity (ROP).
- Current treatments for severe ROP, including laser therapy and anti-VEGF injections, carry potential systemic side effects.
- Dexamethasone eye drops show promise in preventing ROP progression to severe, treatment-requiring stages.
Purpose of the Study:
- To assess the efficacy of timely dexamethasone eye drops in preventing progression to Type 1 ROP.
- To evaluate the safety profile of dexamethasone eye drops in preterm infants.
- To determine if dexamethasone reduces the need for conventional ROP treatments.
Main Methods:
- A multi-center, randomized, double-blind, placebo-controlled trial involving 100 preterm infants (born before 30 weeks gestation) with severe ROP.
- Infants received either dexamethasone eye drops (1 mg/ml) or placebo (saline) until ROP resolution or development of Type 1 ROP.
- Primary outcome: proportion of infants developing Type 1 ROP. Secondary outcomes: adverse events, cortisol and glucose levels, ROP progression timing, recurrence rates, and long-term ophthalmological follow-up.
Main Results:
- The study is designed to evaluate whether dexamethasone intervention reduces the proportion of infants developing Type 1 ROP compared to placebo.
- Adverse events, including elevated intraocular pressure and growth restriction, will be monitored.
- Long-term follow-up will assess visual acuity, refractive errors, and other ophthalmological outcomes.
Conclusions:
- Timely dexamethasone eye drop administration may prevent severe ROP progression to Type 1 ROP, potentially avoiding laser or anti-VEGF treatment.
- This study will provide crucial data on the efficacy and safety of dexamethasone for clinical use and guideline development.
- Further research is needed to confirm these findings and establish optimal treatment protocols.
Background:
As the survival rate of preterm infants continues to rise worldwide, more infants are at risk of developing sight-threatening retinopathy of prematurity (ROP). Destructive retinal laser treatment and intravitreal injections of anti-vascular endothelial growth factor (VEGF), factor, which have potential systemic side effects, are necessary to prevent blindness in severe cases of ROP. Off-label use in clinical settings suggests that dexamethasone eye drops, 1 mg/ml, may prevent the progression of ROP to severe disease (Type 1 ROP) requiring treatment. Our current study aims to assess the efficacy and safety of timely administered dexamethasone eye drops to reduce the need for laser or anti-VEGF ROP treatment in preterm infants.
Methods:
In a randomized prospective interventional, multi-centre, double-blinded trial, we plan to include 100 infants with severe ROP born before gestational age 30 weeks in Sweden. Infants will be randomized to intervention with dexamethasone eye drops (1 mg/ml) (n = 50) or placebo, saline (n = 50) until either ROP is resolved or severe ROP (Type 1 ROP) development occurs, fulfilling ROP treatment criteria. Eye drops will be administered one drop per day or every other day, depending on the severity of ROP, with a maximum duration of 12 weeks. The primary objective is to evaluate whether dexamethasone intervention reduces the proportion of infants developing Type 1 ROP compared to infants receiving a placebo. Adverse events and potential side effects will be recorded, such as high intraocular pressure and growth restriction. Levels of cortisol in saliva and glucose in urine will be measured repeatedly. Secondary outcomes will include the timing of ROP progression, the recurrence rate after ROP treatment and retinal morphology. An ophthalmological follow-up will be initiated at 2 and 5.5 years of age, evaluating visual acuity, refractive errors, strabismus, retinal morphology and ophthalmological complications. All outcomes in the study will be compared between the infants receiving dexamethasone intervention and those receiving placebo.
Discussion:
Timely administration of dexamethasone eye drops may prevent severe ROP from progressing to Type 1 ROP, which requires treatment. This study aims to assess the efficacy and safety of dexamethasone intervention to support its clinical use and national guidelines.
Trial Registration:
EudraCT, 2020-004933-19, registered in January 2021 and CTIS, 2023-505318-97-00, registered in August 2023.
Clinical Trial Number:
Not applicable.
