Long Term Outcome of Intravitreal Ranibizumab for ROP

Retinopathy of Prematurity Clinical Trial

Official title:

Refractive and Biometric Outcome Following Intravitreal Injection of Ranibizumab in Retinopathy of Prematurity: Long -Term Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537065
• Other study ID #: Intravitreal Ranibizumab
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: August 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

premature infants who had a history of intravitreal injection of (Ranibizumab) not less than one year were examined for refractive state and biometry

Description:

Medical records were collected in each group for birth history data, including gestational age (GA), birth weight (BW), and postmenstrual age (PMA) at time of intravitreal injection. The zone and stage of ROP were also recorded. All patients were evaluated for refractive errors and cycloplegic refraction was performed using a handheld auto keratorefractometer (Righton Retinomax K-plus2), and confirmed by retinoscopy examination. Refractive errors were calculated as spherical equivalent and astigmatism in cylinder. The average corneal radius of curvature was measured by handheld auto kerato-refractometer (Righton Retinomax K-plus2). 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Other:
• cycloplegic refraction
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).

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Ameera Gamal Abdelhameed

Country where clinical trial is conducted

Egypt, 

References & Publications (10)

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, García-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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cycloplegic refraction	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
Primary	biometry	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