retinopathy of prematurity
Conditions
Interventions
aflibercept:intravitreal injection of aflibercept
ranibizumab:intravitreal injection of ranibizumab
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Prior to any evaluation, written informed consent must be obtained; 2) Chinese preterm infants with gestational age less than 34 weeks and birth weight less than 2000g in China; 3) According to the international classification of retinopathy of prematurity (ICROP), retinopathy of prematurity was characterized by pre threshold type 1, threshold rop and aggressive posterior retinopathy of prematurity; 4) The general condition is poor and can not tolerate laser treatment; or the pupil is stiff / refractive stroma is unclear, so laser treatment is not available.
Exclusion criteria
Exclusion criteria: 1) Intracranial hemorrhage or heart failure before screening; 2) Any active periocular or ocular infection or inflammation (e.g., blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at screening or baseline; 3) Uncontrolled glaucoma at screening or baseline (intraocular pressure [IOP] >=30 mm Hg at the time of drug treatment, or as judged by the investigator); 4) Eye diseases, including congenital cataract, congenital microphthalmos, persistent primary vitreous hyperplasia, that may interfere with the interpretation of the study results at screening or baseline visit; 5) Any systemic anti VEGF drugs (e.g., bevacizumab [Avastin]) were used before baseline; 6) Current or planned systemic use of drugs known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine / strong chloroquine (Plaquenil), tamoxifen, phenothiazines and ethambutol; 7) Previous treatment:a) anti angiogenic drugs (pegaptanib, Avastin), VEGF Trap, KH902; b) anecortave acetate, corticosteroid; c) protein kinase C inhibitor, small interfering nucleic acid (siRNA); 8) She has received laser photocoagulation, vitrectomy, or any other intraocular surgery; 9) Intraocular / periocular (including Tenon's capsule) corticosteroids were used before baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence time; | — |
Countries
China
Contacts
Public ContactYu Xu
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed