Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027222
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-11-28
Brief Title:
The Early Treatment for Retinopathy of Prematurity Study ETROP
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
The Early Treatment for Retinopathy of Prematurity Study ETROP
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the Early Treatment for Retinopathy of Prematurity Study ETROP is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease
Detailed Description:
At age 5 12 years the oldest age for which follow-up data are available children with threshold ROP who were enrolled in the Cryotherapy for Retinopathy of Prematurity CRYO-ROP -- Outcome Study showed fewer treated eyes 315 percent than control eyes 48 percent that were blind P0001 Of those eyes that had a favorable structural outcome with or without retinal ablation cryotherapy to destroy the fringe of the retina through freezing only a small percentage had best corrected visual acuity better than or equal to 2040 at age 5 12 years 13 percent in the treated group 17 percent in the untreated control group P019 Among the 1398 followed from the 5 large natural history centers of the CRYO-ROP follow-up study children with retinal residua of ROP structural changes had measurable visual acuity that was severly affected and tended to worsen with age The CRYO-ROP Study proved conclusively that peripheral retinal ablation improves the chances of avoiding blindness but at least 80 percent of eyes are left with acuity less than 2040
Two concerns emerged from the CRYO-ROP extensive study on the natural history of ROP and treatment of threshold ROP The first of these is failure of peripheral retinal ablation to eliminate all or nearly all cases of retinal detachment due to ROP In the CRYO-ROP Study 26 percent of eyes with threshold disease in zone II and 78 percent of eyes with zone I threshold disease had an unfavorable structural outcome despite treatment The second concern is that most children who developed threshold ROP disease had visual acuity worse than 2040 even if the eye had a favorable structural outcome
Since no other treatment has yet been shown to be effective in preventing blindness from ROP retinal ablation remains the treatment of choice The ETROP Study will test whether earlier treatment is more effective than treatment at threshold in improving functional visual acuity outcome following ROP as well as determining whether earlier treatment decreases the probability of an unfavorable structural outcome
Earlier treatment is defined as retinal ablation administered to the avascular retina when an eye reaches high risk prethreshold retinopathy of prematurity ROP Prethreshold indicates any Zone I ROP or Zone II stage 2 with plus disease or stage 3 or Zone II with less than 5 contiguous or 8 cumulative clock hours of stage 3 ROP with plus disease Recognizing that a substantial number of eyes undergo spontaneous resolution of ROP eyes will be randomized to early treatment only when high risk for an unfavorable visual acuity outcome is identified High risk will be determined using a risk model analysis program based on longitudinal natural history data obtained from the CRYO-ROP study This model integrates risk factors to assign a risk of progression to blindness without treatment These factors include birth weight gestational age ethnicity singletonmultiple status outborn status Zone on first exam severity of ROP and rate of progression of ROP When an infant develops prethreshold ROP and greater than or equal to 15 percent risk of unfavorable outcome randomization to early treatment of one eye will occur Visual acuity outcome will be measured by masked observers after wearing best correction using the Teller Acuity Card Procedure at 9 months corrected age
Two concerns emerged from the CRYO-ROP extensive study on the natural history of ROP and treatment of threshold ROP The first of these is failure of peripheral retinal ablation to eliminate all or nearly all cases of retinal detachment due to ROP In the CRYO-ROP Study 26 percent of eyes with threshold disease in zone II and 78 percent of eyes with zone I threshold disease had an unfavorable structural outcome despite treatment The second concern is that most children who developed threshold ROP disease had visual acuity worse than 2040 even if the eye had a favorable structural outcome
Since no other treatment has yet been shown to be effective in preventing blindness from ROP retinal ablation remains the treatment of choice The ETROP Study will test whether earlier treatment is more effective than treatment at threshold in improving functional visual acuity outcome following ROP as well as determining whether earlier treatment decreases the probability of an unfavorable structural outcome
Earlier treatment is defined as retinal ablation administered to the avascular retina when an eye reaches high risk prethreshold retinopathy of prematurity ROP Prethreshold indicates any Zone I ROP or Zone II stage 2 with plus disease or stage 3 or Zone II with less than 5 contiguous or 8 cumulative clock hours of stage 3 ROP with plus disease Recognizing that a substantial number of eyes undergo spontaneous resolution of ROP eyes will be randomized to early treatment only when high risk for an unfavorable visual acuity outcome is identified High risk will be determined using a risk model analysis program based on longitudinal natural history data obtained from the CRYO-ROP study This model integrates risk factors to assign a risk of progression to blindness without treatment These factors include birth weight gestational age ethnicity singletonmultiple status outborn status Zone on first exam severity of ROP and rate of progression of ROP When an infant develops prethreshold ROP and greater than or equal to 15 percent risk of unfavorable outcome randomization to early treatment of one eye will occur Visual acuity outcome will be measured by masked observers after wearing best correction using the Teller Acuity Card Procedure at 9 months corrected age
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None