Stahl, Andreas and Krohne, Tim U. and Eter, Nicole and Oberacher-Velten, Isabel and Guthoff, Rainer and Meltendorf, Synke and Ehrt, Oliver and Aisenbrey, Sabine and Roider, Johann and Gelding, Heinrich and Jandeck, Claudia and Smith, Lois E. H. and Walz, Johanna M. (2018) Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity A Randomized Clinical Trial. JAMA PEDIATRICS, 172 (3). pp. 278-286. ISSN 2168-6203, 2168-6211
Full text not available from this repository. (Request a copy)Abstract
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 MEASURES: The 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | ENDOTHELIAL GROWTH-FACTOR; INTRAVITREAL BEVACIZUMAB; SERUM CONCENTRATIONS; PHARMACOKINETICS; REACTIVATION; THERAPY; INFANTS; INJECTION; AVASTIN; VEGF; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Augenheilkunde |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 05 Mar 2020 09:50 |
| Last Modified: | 05 Mar 2020 09:50 |
| URI: | https://pred.uni-regensburg.de/id/eprint/14955 |
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