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Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity

Information source: University of South Alabama
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinopathy of Prematurity; Retinal Detachment; Blindness

Intervention: ACULAR (Drug); REFRESH TEARS (Drug); placebo (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: University of South Alabama

Official(s) and/or principal investigator(s):
Fabien G Eyal, M.D., Principal Investigator, Affiliation: University Of South Alabama, Children's & Women's Hospital

Summary

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%.

Clinical Details

Official title: Topical Application of ACULAR a Randomized, Vehicle Controlled Clinical Trial: Efficiency in Inhibiting Proliferative Retinopathy of Prematurity

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study

Primary outcome: Efficacy of ACULAR compared to placebo in inhibiting the development of retinopahty of prematurity in a high risk very immature preterm group of infants

Detailed description: 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.

ACULARĀ® (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.

Eligibility

Minimum age: N/A. Maximum age: 15 Days. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All preterm infants of gestational age less or equal to 28 weeks completed gestational

age and 10 to 15 days of postnatal age admitted to our regional NICU

Locations and Contacts

Division of Neonatology, Children's & Women's Hospital, University of South Alabama, Mobile, Alabama 36604-3391, United States
Additional Information

Starting date: November 2005
Ending date: December 2009
Last updated: March 12, 2008

Page last updated: June 20, 2008

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