Retinopathy of Prematurity Clinical Trial
Official title:
Topical Application of ACULAR a Randomized, Vehicle Controlled Clinical Trial: Efficiency in Inhibiting Proliferative Retinopathy of Prematurity
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or decrease its severity.In this study ACULAR will be compared to a placebo (artificial tear). The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to severe ROP (grade II and above)by 50%.
Each year ROP affects an estimated 14,000-16,000 premature, low birth weight infants in the United States and thousands more worldwide, making it a leading cause of vision loss in children. Of these cases, approximately 1500 infants will develop severe ROP that requires surgical treatment. Despite those treatment, about 400-600 infants with severe ROP still become legally blind each year. ACULAR® (Ketorolac eye drop) is a member of nonsteroidal anti-inflammatory drugs (NSAIDs) available for toipcal ocular use. ACULAR acts as prostaglandin inhibitor and as such decrease prostaglandin E2 production. An increase in prostaglandin production has been associated with various inflammatory eye disease.For instance ACULAR has been shown to be effective in preventing the post cataract surgery inflammation that result in macular edema in adults. Activation of the prostaglandin cascade has been demonstrated in animal models of ROP. A previous non randomized study using ACULAR for ROP prevention has shown a possible beneficial effect and no observed adverse effect. To clearly demonstrated and confirm this finding a randomized study is thus necessary before one can advocate its use for prevention of ROP.The medication is FDA approved in pediatrics for allergic conjunctivitis and post surgical ocular inflammation. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05043077 -
Efficacy and Safety of Mydriatic Microdrops for Retinopathy Of Prematurity Screening
|
Phase 4 | |
Completed |
NCT04838665 -
Changes in Vital Signs and Pupil Diameter Related to Pharmacologic Mydriasis in Premature Infants: A Randomized Double Blind Clinical Study
|
Phase 4 | |
Completed |
NCT04408807 -
Stress Induced by Screening for Retinopathy of Prematurity - Should Speculum and Indentation Rather be Avoided
|
N/A | |
Recruiting |
NCT03083431 -
Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity
|
Phase 2 | |
Enrolling by invitation |
NCT04985448 -
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
|
||
Recruiting |
NCT02090322 -
Bevacizumab 0.500MG Intravitreal There Isn't Lower Than 0.625MG in the Treatment of ROP Type 1
|
N/A | |
Completed |
NCT00872664 -
Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids
|
N/A | |
Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
Completed |
NCT06452524 -
Prematurity and Ophthalmological Changes
|
||
Completed |
NCT04101721 -
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity
|
Phase 3 | |
Enrolling by invitation |
NCT02050971 -
Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates
|
Phase 1 | |
Terminated |
NCT01335113 -
A Scan Ultrasonography in the Evaluation of Retinopathy of Prematurity
|
||
Active, not recruiting |
NCT00027222 -
The Early Treatment for Retinopathy of Prematurity Study (ETROP)
|
Phase 2/Phase 3 | |
Recruiting |
NCT06109285 -
Validation of i-ROP DL to Detect More Than Mild ROP
|
N/A | |
Completed |
NCT02014454 -
Safety and Efficacy of Propranolol Eye Drops in Treating Retinopathy of Premature
|
Phase 2 | |
Completed |
NCT01861470 -
REDEXAM - Reducing Painful Eye Examinations in Preterm Infants
|
N/A | |
Completed |
NCT05701124 -
Intravitreal Ranibizumab Injection for Aggressive Versus Type 1 Prethreshold Retinopathy of Prematurity
|
Phase 3 | |
Completed |
NCT04092127 -
Pain of Premature Babies and RetCam (DOLICAM)
|
||
Completed |
NCT04621136 -
PhaseI/II Investigator-Initiated Trial to Investigate Safety and Efficacy of Ripasudil in Patients With Retinopathy of Prematurity
|
Phase 1/Phase 2 | |
Completed |
NCT04883931 -
Mother Milk as a Eye Drop & Premature Retinopathy
|
N/A |