Retinopathy of Prematurity (ROP)
Multicenter Trial of Cryotherapy for Retinopathy of Prematurity: ophthalmological outcomes at 10 years (CRYO-ROP), 2001 ⏩
n=247, 10y
Study question: Cryo versus control for threshold ROP
Study Results: Fewer unfavorable outcomes in tx vs control: 44.4% vs 62.1% for VA and 27.2% vs 47.9% for fundus status. Total RD had continued to occur in control eyes, 38.6% at 5y to 41.4% at 10y, while treated eyes remained stable (at 22.0%). A previously disturbing trend that more control eyes than tx eyes had visual acuity of 20/40 or better (in the 5(1/2)-year report) was no longer present at 10y. Eyes s/p cryotherapy were found at least as likely as control eyes to have 20/40 or better VA.
FINAL RESULTS OF THE EARLY TREATMENT FOR RETINOPATHY OF PREMATURITY RANDOMIZED TRIAL (ETROP), 2004 ⏩
n=401, 9m
Study question: bilateral high-risk pre-threshold ROP: one eye early retinal ablative treatment vs fellow eye managed conventionally. Study Results: Unfavorable VA outcomes with earlier treatment 14.3% vs 19.8%. Unfavorable structural outcomes reduced with tx to 9% vs 15.6%. Supported retinal ablative therapy for type I ROP, defined as zone I, any stage with plus disease; zone I, stage 3 without plus disease; or zone II, stage 2 or 3 with plus disease. “Wait and watch” approach to type II ROP, defined as zone I, stage 1 and 2 without plus disease, or zone II, stage 3 without plus disease.
Efficacy of Intravitreal Bevacizumab for Stage 3+ Retinopathy of Prematurity (BEAT ROP), 2011 ⏩ and ⏩ or ⏩
n=300 eyes, 12m
Study question: IVT bevacizumab (0.625 mg in 0.025 ml of solution)) VS Laser for zone I or zone II stage 3 plus disease. Tx was bilateral
Study results: ROP recurred in 4 infants in the bevacizumab group (6 of 140 eyes [4%]) and 19 infants in the laser group (32 of 146 eyes [22%]). A significant treatment effect was found for zone I but not for zone II. Recurrence was early in laser tx (6w) and much later in ant-VEGF group (16w) requiring longer follow-up.
Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity (RANBOW), unpublished ⏩ and ⏩
n=225, 26w
Study question: Lucentis, 0.1 mg VS 0.2 mg VS laser for bilateral ROP with one of the following retinal findings in each eye: Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior retinopathy of prematurity (AP-ROP). Study results: treatment success 80% for 0.2mg, 75% for 0.1mg and 66.2% for laser. Not statistically significant as p was 0.0254 rather than the required 0.025. Extension study on the way with results due 2020. $ Novarits
Abbreviations sued on this page:
$ - study funding
m - months
VA- Visual acuity
VEGF - vascular endothelial growth factor
VS - versus
w - weeks
RD - retinal detachment
ROP - retinpathy of rematurity
s/p - status post
y- years
----------------------------------------
🚧 This page is under constriction - we will make it better soon. Please be patient. If you have any suggestions we will be happy to hear about it through the form below.
n=247, 10y
Study question: Cryo versus control for threshold ROP
Study Results: Fewer unfavorable outcomes in tx vs control: 44.4% vs 62.1% for VA and 27.2% vs 47.9% for fundus status. Total RD had continued to occur in control eyes, 38.6% at 5y to 41.4% at 10y, while treated eyes remained stable (at 22.0%). A previously disturbing trend that more control eyes than tx eyes had visual acuity of 20/40 or better (in the 5(1/2)-year report) was no longer present at 10y. Eyes s/p cryotherapy were found at least as likely as control eyes to have 20/40 or better VA.
FINAL RESULTS OF THE EARLY TREATMENT FOR RETINOPATHY OF PREMATURITY RANDOMIZED TRIAL (ETROP), 2004 ⏩
n=401, 9m
Study question: bilateral high-risk pre-threshold ROP: one eye early retinal ablative treatment vs fellow eye managed conventionally. Study Results: Unfavorable VA outcomes with earlier treatment 14.3% vs 19.8%. Unfavorable structural outcomes reduced with tx to 9% vs 15.6%. Supported retinal ablative therapy for type I ROP, defined as zone I, any stage with plus disease; zone I, stage 3 without plus disease; or zone II, stage 2 or 3 with plus disease. “Wait and watch” approach to type II ROP, defined as zone I, stage 1 and 2 without plus disease, or zone II, stage 3 without plus disease.
Efficacy of Intravitreal Bevacizumab for Stage 3+ Retinopathy of Prematurity (BEAT ROP), 2011 ⏩ and ⏩ or ⏩
n=300 eyes, 12m
Study question: IVT bevacizumab (0.625 mg in 0.025 ml of solution)) VS Laser for zone I or zone II stage 3 plus disease. Tx was bilateral
Study results: ROP recurred in 4 infants in the bevacizumab group (6 of 140 eyes [4%]) and 19 infants in the laser group (32 of 146 eyes [22%]). A significant treatment effect was found for zone I but not for zone II. Recurrence was early in laser tx (6w) and much later in ant-VEGF group (16w) requiring longer follow-up.
Randomized, Controlled Study Evaluating the Efficacy and Safety of RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity (RANBOW), unpublished ⏩ and ⏩
n=225, 26w
Study question: Lucentis, 0.1 mg VS 0.2 mg VS laser for bilateral ROP with one of the following retinal findings in each eye: Zone I, stage 1+, 2+, 3 or 3+ disease, or Zone II, stage 3+ disease, or Aggressive posterior retinopathy of prematurity (AP-ROP). Study results: treatment success 80% for 0.2mg, 75% for 0.1mg and 66.2% for laser. Not statistically significant as p was 0.0254 rather than the required 0.025. Extension study on the way with results due 2020. $ Novarits
Abbreviations sued on this page:
$ - study funding
m - months
VA- Visual acuity
VEGF - vascular endothelial growth factor
VS - versus
w - weeks
RD - retinal detachment
ROP - retinpathy of rematurity
s/p - status post
y- years
----------------------------------------
🚧 This page is under constriction - we will make it better soon. Please be patient. If you have any suggestions we will be happy to hear about it through the form below.
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