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Short-term Outcomes After Very Low-Dose Intravitreous Bevacizumab for Retinopathy of Prematurity
David K Wallace1, Raymond T Kraker2, Sharon F Freedman3
1Indiana University Department of Ophthalmology, Indianapolis.
Insights
Lowering the dose of intravitreous bevacizumab for retinopathy of prematurity (ROP) is safe and effective. Doses as low as 0.004 mg show promise in treating ROP while minimizing systemic risks.
Area of Science:
- Ophthalmology
- Neonatology
- Pharmacology
Background:
- Intravitreous bevacizumab (0.25-0.625 mg) is a standard treatment for type 1 retinopathy of prematurity (ROP).
- Concerns exist regarding systemic toxicity and potential neurodevelopmental delays associated with current dosages.
- Previous studies suggest lower doses may be effective for ROP.
Purpose of the Study:
- To determine the lowest effective dose of intravitreous bevacizumab for treating severe type 1 ROP.
- To evaluate the safety and efficacy of dose de-escalation in premature infants with ROP.
Main Methods:
- A masked, multicenter, dose de-escalation study enrolled 59 premature infants with type 1 ROP.
- Infants received intravitreous bevacizumab at doses of 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg.
- Success was defined by ROP improvement and absence of recurrence within 4 weeks post-injection.
Main Results:
- A 100% success rate was observed with 0.016 mg and 0.008 mg doses.
- The 0.004 mg dose achieved a 90% success rate (9/10 eyes).
- The 0.002 mg dose showed a lower success rate of 74% (17/23 eyes).
Conclusions:
- A dose of 0.004 mg intravitreous bevacizumab appears to be the lowest effective dose for ROP.
- Further research is needed to confirm the efficacy of very low-dose bevacizumab and its systemic effects.
Importance:
Intravitreous bevacizumab (0.25 mg to 0.625 mg) is commonly used to treat type 1 retinopathy of prematurity (ROP), but there are concerns about systemic toxicity, particularly the risk of neurodevelopmental delay. A much lower dose may be effective for ROP while reducing systemic risk. Previously, after testing doses of 0.25 mg to 0.031 mg, doses as low as 0.031 mg were found to be effective in small cohorts of infants.
Objective:
To find the lowest dose of intravitreous bevacizumab effective for severe ROP.
Design, Setting, And Participants:
Between April 2017 and May 2019, 59 premature infants with type 1 ROP in 1 or both eyes were enrolled in a masked, multicenter, dose de-escalation study. In cohorts of 10 to 14 infants, 1 eye per infant received 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg of intravitreous bevacizumab. Diluted bevacizumab was prepared by individual research pharmacies and delivered using 300-µL syringes with 5/16-inch, 30-guage fixed needles. Analysis began July 2019.
Interventions:
Bevacizumab intravitreous injections at 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg.
Main Outcomes And Measures:
Success was defined as improvement by 4 days postinjection and no recurrence of type 1 ROP or severe neovascularization requiring additional treatment within 4 weeks.
Results:
Fifty-five of 59 enrolled infants had 4-week outcomes completed; the mean (SD) birth weight was 664 (258) g, and the mean (SD) gestational age was 24.8 (1.6) weeks. A successful 4-week outcome was achieved for 13 of 13 eyes (100%) receiving 0.016 mg, 9 of 9 eyes (100%) receiving 0.008 mg, 9 of 10 eyes (90%) receiving 0.004 mg, but only 17 of 23 eyes (74%) receiving 0.002 mg.
Conclusions And Relevance:
These data suggest that 0.004 mg may be the lowest dose of bevacizumab effective for ROP. Further investigation is warranted to confirm effectiveness of very low-dose intravitreous bevacizumab and its effect on plasma vascular endothelial growth factor levels and peripheral retinal vascularization.
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