The German ROP Registry: data from 90 infants treated for retinopathy of prematurity

Walz, Johanna M.; Bemme, Sebastian; Pielen, Amelie; Aisenbrey, Sabine; Breuß, H; Alex, Anne F.; Wagenfeld, Lars; Schiedel, S; Krohne, Tim U.; Stahl, Andreas

doi:10.1111/aos.13069

Cited by 37 publications

(40 citation statements)

References 21 publications

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“…Nevertheless, anti-VEGF therapy is being used with increasing frequency. 17 To our knowledge, this study is the first to systematically report safety parameters from a double-blind prospective clinical anti-VEGF trial in ROP. Overall, 3 patients died in CARE-ROP.…”

Section: Discussionmentioning

confidence: 94%

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Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

Stahl

Krohne

Eter³

et al. 2018

JAMA Pediatr

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126

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for the Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity (CARE-ROP) Study Group IMPORTANCE Anti-vascular endothelial growth factor (VEGF) therapies are a novel treatment option in retinopathy of prematurity (ROP). Data on dosing, efficacy, and safety are insufficient.OBJECTIVE To investigate lower doses of anti-VEGF therapy with ranibizumab, a substance with a significantly shorter systemic half-life than the standard treatment, bevacizumab.DESIGN, SETTING, AND PARTICIPANTS This randomized, multicenter, double-blind, investigator-initiated trial at 9 academic medical centers in Germany compared ranibizumab doses of 0.12 mg vs 0.20 mg in infants with bilateral aggressive posterior ROP; ROP stage 1 with plus disease, 2 with plus disease, or 3 with or without plus disease in zone I; or ROP stage 3 with plus disease in posterior zone II. Patients were recruited between September 2014 and August 2016. Twenty infants were screened and 19 were randomized.INTERVENTIONS All infants received 1 baseline ranibizumab injection per eye. Reinjections were allowed in case of ROP recurrence after at least 28 days. MAIN OUTCOMES AND MEASURESThe primary end point was the number of infants who did not require rescue therapy at 24 weeks. Key secondary end points included time-to-event analyses, progression of physiologic vascularization, and plasma VEGF levels. Stages of ROP were photodocumented and reviewed by an expert committee.RESULTS Nineteen infants with ROP were enrolled (9 [47.4%] female; median [range] postmenstrual age at first treatment, 36.4 [34.7-39.7] weeks), 3 of whom died during the study (1 in the 0.12-mg group and 2 in the 0.20-mg group). Of the surviving infants, 8 (88.9%) (17 eyes [94.4%]) in the 0.12-mg group and 6 (85.7%) (13 eyes [92.9%]) in the 0.20-mg group did not require rescue therapy. Both ranibizumab doses were equally successful in controlling acute ROP (Cochran-Mantel-Haenszel analysis; odds ratio, 1.88; 95% CI, 0.26-13.49; P = .53). Physiologic intraretinal vascularization was superior in the 0.12-mg group. The VEGF plasma levels were not systematically altered in either group.CONCLUSIONS AND RELEVANCE This pilot study demonstrates that ranibizumab is effective in controlling acute ROP and that 24% of the standard adult dose (0.12 mg) appears equally effective as 40% (0.20 mg). Superior vascularization of the peripheral retina with 0.12 mg of ranibizumab indicates that the lower dose may be favorable. Unchanged plasma VEGF levels point toward a limited systemic drug exposure after ranibizumab.

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Section: Discussionmentioning

confidence: 94%

“…This proportion is higher than in the BEAT-ROP population but comparable to several other studies. 4,17,25,26 Recurrence of ROP was equally distributed across the 2 dose groups. It is important to note that retreatments are very different in nature from rescue therapy.…”

Section: Discussionmentioning

confidence: 99%

Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

Stahl

Krohne

Eter³

et al. 2018

JAMA Pediatr

Self Cite

126

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“…For example, the incidence of ROP requiring treatment at certain centres in Germany was 3.2% of all infants screened 13. This study was based on a registry including several centres providing data obtained in routine clinical practice.…”

Section: Discussionmentioning

confidence: 99%

Incidence of retinopathy of prematurity (ROP) and ROP treatment in Switzerland 2006–2015: a population-based analysis

Gerull¹,

Brauer

Bassler

et al. 2017

Arch Dis Child Fetal Neonatal Ed

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“…Ocular neovascularization (NV) is the primary cause of blindness in a wide range of ocular diseases such as diabetic retinopathy (DR), age-related macular degeneration (AMD), retinopathy of prematurity (ROP), central and branch retina vein occlusion (CRVO and BRVO), trauma and various infl ammatory ocular diseases (1,2). Retinal and choroidal vascular diseases constitute the most common causes of moderate and severe vision loss in developed countries (3).…”

Section: Introductionmentioning

confidence: 99%

MicroRNA-370 suppresses the retinal capillary endothelial cell growth by targeting KDR gene

Wang¹,

Chen²

2017

BLL

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The German ROP Registry: data from 90 infants treated for retinopathy of prematurity

Cited by 37 publications

References 21 publications

Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

Incidence of retinopathy of prematurity (ROP) and ROP treatment in Switzerland 2006–2015: a population-based analysis

MicroRNA-370 suppresses the retinal capillary endothelial cell growth by targeting KDR gene

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