In:
British Journal of Ophthalmology, BMJ, Vol. 105, No. 2 ( 2021-02), p. 253-257
Abstract:
To evaluate the long-term effects of treat-and-extend dosing of ranibizumab with and without navigated focal laser for diabetic macular oedema (DME). Methods This is a multicentre, randomised clinical trial where 150 eyes were randomised into three cohorts; Monthly (n=30), TReat and EXtend without macular laser photocoagulation (TREX; n=60), and treat and extend with angiography-GuIded macular LAser photocoagulation (GILA; n=60). During the first 2 years, eyes either received ranibizumab 0.3 mg every 4 weeks or underwent treat-and-extend ranibizumab with or without angiography-guided laser therapy. In the third year, all eyes were treated as needed with ranibizumab for 〉 5 letters vision loss or if the central retinal thickness (CRT) was 〉 325 µm, and all eyes were eligible to receive focal laser. Results 109 eyes (73%) completed the 3-year end-point. At week 156, mean best-corrected visual acuity (BCVA) and CRT improved by 6.9, 9.7, 9.5 letters (p=0.60) and 129, 138, 165 µm (p=0.39), in the Monthly, TREX and GILA cohorts, respectively. These improvements were reached prior to week 104 and no significant changes occurred from week 104 to week 156 (BCVA: p=0.34; CRT: p=0.36). The mean number of injections in the third year was 3.0, 3.1, and 2.4 in the Monthly, TREX and GILA cohorts, respectively (p=0.56). 86 eyes (79%) required at least one ranibizumab injection in the third year. Conclusion The improvements achieved after 2 years of treat-and-extend ranibizumab for DME were maintained in the third year with a mean of 3 intravitreal injections. Trial registration number FDA IND 119146, NCT01934556 .
Type of Medium:
Online Resource
ISSN:
0007-1161
,
1468-2079
DOI:
10.1136/bjophthalmol-2020-316176
Language:
English
Publisher:
BMJ
Publication Date:
2021
detail.hit.zdb_id:
1482974-5
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