Universität zu Köln

Stahl, Andreas ORCID: 0000-0002-8013-7597, Bruender, Marie-Christine, Lagreze, Wolf A., Molnar, Fanni E., Barth, Teresa, Eter, Nicole, Guthoff, Rainer, Krohne, Tim U. and Pfeil, Johanna M. (2022). Ranibizumab in retinopathy of prematurity - one-year follow-up of ophthalmic outcomes and two-year follow-up of neurodevelopmental outcomes from the CARE-ROP study. Acta Ophthalmol., 100 (1). S. E91 - 9. HOBOKEN: WILEY. ISSN 1755-3768

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Abstract

Purpose The primary endpoint results from the comparing alternative ranibizumab dosages for safety and efficacy in retinopathy of prematurity (CARE-ROP) core study identified ranibizumab as an effective treatment to control acute retinopathy of prematurity (ROP). This study reports the 1- and 2-year follow-up data focusing on long-term functional outcomes and safety. Methods The CARE-ROP trial compared 0.12 mg versus 0.20 mg ranibizumab in 20 infants with ROP in a multicentric, prospective, randomized, double-blind, controlled study design. Sixteen patients entered the follow-up period. An ophthalmologic assessment at one year postbaseline was acquired from all 16 patients and a neurodevelopmental assessment at two years postbaseline was acquired from 15 patients. Results Fifteen of 16 infants were able to fixate and follow moving objects at one year postbaseline treatment. One child progressed to stage 5 ROP bilaterally between the end of the core study and the 1-year follow-up (first seen at PMA 75 weeks). Mean spherical equivalents were -1.9 diopters (D) and -0.75 D in the 0.12 mg and the 0.20 mg treatment arms. Strabismus was present in seven and nystagmus in five out of 16 infants. Mental development scores were within normal limits in six out of ten patients with available data. No statistically significant difference was observed between the two treatment arms. Conclusion Neurodevelopmental and functional ocular outcomes 1 and 2 years after treatment with ranibizumab are reassuring regarding long-term safety. Late reactivation of ROP, however, represents a challenge during the follow-up phase and it is of utmost importance that regular follow-ups are maintained.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Stahl, Andreas UNSPECIFIED orcid.org/0000-0002-8013-7597 UNSPECIFIED Bruender, Marie-Christine UNSPECIFIED UNSPECIFIED UNSPECIFIED Lagreze, Wolf A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Molnar, Fanni E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Barth, Teresa UNSPECIFIED UNSPECIFIED UNSPECIFIED Eter, Nicole UNSPECIFIED UNSPECIFIED UNSPECIFIED Guthoff, Rainer UNSPECIFIED UNSPECIFIED UNSPECIFIED Krohne, Tim U. UNSPECIFIED UNSPECIFIED UNSPECIFIED Pfeil, Johanna M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-594037
DOI:	10.1111/aos.14852
Journal or Publication Title:	Acta Ophthalmol.
Volume:	100
Number:	1
Page Range:	S. E91 - 9
Date:	2022
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1755-3768
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language Ophthalmology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59403