Long Term Outcome of Intravitreal Ranibizumab for ROP

NCT04537065 | Completed

• 1 other identifier: Intravitreal Ranibizumab
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

preterm infants without ROP

Other: cycloplegic refraction

preterm infants with regressed ROP

Other: cycloplegic refraction

preterm infants with threshold ROP

Other: cycloplegic refraction

full-term infants

Other: cycloplegic refraction

Interventions

cycloplegic refraction OTHER

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).

Also known as: Biometry

full-term infants; preterm infants with regressed ROP; preterm infants with threshold ROP; preterm infants without ROP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical records of premature infants were collected from Egyptian Neonatal Network (EGNN) data base

You may qualify if:

• 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

You may not qualify if:

• Premature infants who received intravitreal injection of (Ranibizumab) less than one year or had any ocular pathology

Sponsors & Collaborators

• Ameera Gamal Abdelhameed: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (10)

• 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.

  PMID: 23719304 BACKGROUND

• 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.

  PMID: 23205771 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 25886603 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23221964 BACKGROUND

• 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.

  PMID: 29713524 BACKGROUND

• 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.

  PMID: 24141714 BACKGROUND

• 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.

  PMID: 19036998 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Mydriatics; Biometry

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Rania MR Bassiouny, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Ophthalmology

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 3, 2020
• Study Start: April 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: September 3, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)