Recurrent VH was defined as fresh hemorrhage developing after resolution of previous hemorrhage or worsening of current hemorrhage.
VH clearance time was defined as the time until vessels in the posterior pole were clearly visible. Best-corrected visual acuity (BCVA) was taken with a Snellen acuity chart and converted to logarithm of minimum angle of resolution (logMAR) equivalent units for statistical calculations. The intravitreal injection was performed under sterile conditions and using topical anesthetic 3.5 mm from the limbus via a 30-gauge needle. Ziv-aflibercept 0.05 mL (1.25 mg aflibercept) was prepared and injected according to standard protocols (compounding under sterile conditions with storage at 4 ☌ for 4 weeks). The exclusion criteria were as follows: patients with a single eye, history of glaucoma, ocular inflammation, and tractional retinal detachment (by B-scan or prior history).
Dense VH was defined as obscuration of posterior pole details and visual drop to 20/80 or worse. Inclusion criteria were age of 18 years or older with type 1 or 2 diabetes mellitus, PDR (neovascularization at the optic disc or elsewhere) with recurrent fresh dense VH, prior PRP of more than 2 months duration. PDR eyes in our study had persistent active retinal neovascularization despite prior complete PRP (confluent laser marks covering from equator to the retinal periphery with a minimum of 1200 laser spots). Eligible patients with dense VH secondary to PDR with visual acuity equal or worse than 20/80 were enrolled in the study. Informed consent was obtained from each participant. All participants were informed in detail about the nature of off-label use of this medication and the possible risks. This study adhered to the tenets of the Declaration of Helsinki. The study and data accumulation were carried out with approval from the Institutional Review Boards at each site (registered as NCT 02486484). This study was performed at 3 sites (Lebanon, Egypt and India). This prospective uncontrolled clinical study included 27 eyes of 21 patients from January 2015 to August 2018. IVZ injections had good short-term safety and efficacy for the therapy of new or recurrent VH in previously lasered eyes with PDR reducing somewhat the need for vitrectomy. No ocular or systemic adverse effects were noted. Eyes, which required multiple injections, the interval period between injections for recurrent VH was 6.4 ± 5.2 months. Mean time for visual recovery and/or VH clearance was 5.7 ± 3.3 weeks. Mean logMAR BCVA at baseline was 1.41 ± 1.26 (Snellen equivalent 20/514) and at the last visit 0.55 ± 0.61 (Snellen equivalent 20/70) with a mean gain of 0.86 EDTRS line (paired student t test = 5.1 p ≤ 0.001). Mean age of study patients was 61.3 ± 14.1 years with mean duration of diabetes mellitus of 22.6 ± 7.8 years. Twenty-seven eyes of 21 patients were included in the study. Demographic characteristics of the patients, baseline and final logMar visual acuity, number of injections, VH clearance time, and need for vitrectomy were recorded.
In a prospective multicenter study, previously lasered eyes who had dense VH from PDR underwent intravitreal injection of ziv-aflibercept (IVZ) (1.25 mg aflibercept).
To evaluate the safety and efficacy of intravitreal ziv-aflibercept (IVZ) in the management of vitreous hemorrhage (VH) in eyes with previously lasered proliferative diabetic retinopathy (PDR).
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