- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04537065
Long Term Outcome of Intravitreal Ranibizumab for ROP
Refractive and Biometric Outcome Following Intravitreal Injection of Ranibizumab in Retinopathy of Prematurity: Long -Term Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypt
- Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year
- Three control groups with age and sex matched were included for comparison. First group included premature infants who had ROP that regressed spontaneously without intervention. Second group was corresponded to premature infants who were diagnosed to have normal retinal vasculature from the first examination after birth. The third group belonged to full term babies
Exclusion Criteria:
- Premature infants who received intravitreal injection of (Ranibizumab) less than one year or had any ocular pathology
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
preterm infants without ROP
|
Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder. The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek).
Other Names:
|
preterm infants with regressed ROP
|
Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder. The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek).
Other Names:
|
preterm infants with threshold ROP
|
Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder. The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek).
Other Names:
|
full-term infants
|
Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder. The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cycloplegic refraction
Time Frame: 1 year after injection
|
Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2).
Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder
|
1 year after injection
|
biometry
Time Frame: 1 year after injection
|
The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek).
Examination under sedation was performed for uncooperative children.
|
1 year after injection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rania MR Bassiouny, MD, Mansoura University
Publications and helpful links
General Publications
- World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
- Lin CJ, Chen SN, Tseng CC, Chang YC, Hwang JF. Effects of ranibizumab on very low birth weight infants with stage 3 retinopathy of prematurity: A preliminary report. Taiwan Journal of Ophthalmology 2012; 2: 136-139
- Zin A, Gole GA. Retinopathy of prematurity-incidence today. Clin Perinatol. 2013 Jun;40(2):185-200. doi: 10.1016/j.clp.2013.02.001.
- Isaza G, Arora S, Bal M, Chaudhary V. Incidence of retinopathy of prematurity and risk factors among premature infants at a neonatal intensive care unit in Canada. J Pediatr Ophthalmol Strabismus. 2013 Jan-Feb;50(1):27-32. doi: 10.3928/01913913-20121127-02. Epub 2012 Dec 4.
- Menke MN, Framme C, Nelle M, Berger MR, Sturm V, Wolf S. Intravitreal ranibizumab monotherapy to treat retinopathy of prematurity zone II, stage 3 with plus disease. BMC Ophthalmol. 2015 Mar 8;15:20. doi: 10.1186/s12886-015-0001-7.
- Bassiouny, RaniaM.R. & Ellakkany, RasheedS & Aboelkhair, SamyA & Mohsen, TarekA & Othman, IhabS. (2017). Incidence and risk factors of retinopathy of prematurity in neonatal intensive care units: Mansoura, Egypt. Journal of the Egyptian Ophthalmological Society. 110. 71. 10.4103/ejos.ejos_25_17.
- Castellanos MA, Schwartz S, Garcia-Aguirre G, Quiroz-Mercado H. Short-term outcome after intravitreal ranibizumab injections for the treatment of retinopathy of prematurity. Br J Ophthalmol. 2013 Jul;97(7):816-9. doi: 10.1136/bjophthalmol-2012-302276. Epub 2012 Dec 8.
- Chen YC, Chen SN, Yang BC, Lee KH, Chuang CC, Cheng CY. Refractive and Biometric Outcomes in Patients with Retinopathy of Prematurity Treated with Intravitreal Injection of Ranibizumab as Compared with Bevacizumab: A Clinical Study of Correction at Three Years of Age. J Ophthalmol. 2018 Mar 11;2018:4565216. doi: 10.1155/2018/4565216. eCollection 2018.
- Cook A, White S, Batterbury M, Clark D. Ocular growth and refractive error development in premature infants with or without retinopathy of prematurity. Invest Ophthalmol Vis Sci. 2008 Dec;49(12):5199-207. doi: 10.1167/iovs.06-0114.
- Dawson DG, Watsky MA, Geroski DH, Edelhauser HF. Cornea and sclera. In: Tasman W, Jaeger EA, editors. Duane's ophthalmology [CD-ROM]. Philadelphia: Lippincott Williams & Wilkins; 2007. Chapter 4
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Intravitreal Ranibizumab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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