Intravitreal Ranibizumab in Recurrent ROP

NCT04539106 | Completed

• 1 other identifier: intravitreal Ranibizumab reinj
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

A retrospective study included reviewing of medical records of preterm babies who were admitted in neonatal intensive care unit (NICU) of Mansoura University children hospital (MUCH) or referred from nearby hospitals for ROP screening during the period from March 2013 to February 2020.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• full vascularization of the retina

  Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed.

  6 months

Interventions

intravitreal injection of Ranibizumab DRUG

intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus

Eligibility Criteria

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

Study Population

ROP reactivation was defined as any of the following: recurrent plus disease, recurrent neovascularization, or reformation of ridge despite treatment

You may qualify if:

• patients received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) and developed recurrence of ROP

Sponsors & Collaborators

• Ameera Gamal Abdelhameed: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (13)

• Lad EM, Hernandez-Boussard T, Morton JM, Moshfeghi DM. Incidence of retinopathy of prematurity in the United States: 1997 through 2005. Am J Ophthalmol. 2009 Sep;148(3):451-8. doi: 10.1016/j.ajo.2009.04.018. Epub 2009 Jul 9.

  PMID: 19541285 BACKGROUND

• Gilbert C. Retinopathy of prematurity: a global perspective of the epidemics, population of babies at risk and implications for control. Early Hum Dev. 2008 Feb;84(2):77-82. doi: 10.1016/j.earlhumdev.2007.11.009. Epub 2008 Jan 29.

  PMID: 18234457 BACKGROUND

• Kwinta P, Bik-Multanowski M, Mitkowska Z, Tomasik T, Pietrzyk JJ. The clinical role of vascular endothelial growth factor (VEGF) system in the pathogenesis of retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2008 Oct;246(10):1467-75. doi: 10.1007/s00417-008-0865-9. Epub 2008 Jun 11.

  PMID: 18546007 BACKGROUND

• Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Cryotherapy for Retinopathy of Prematurity Cooperative Group. Arch Ophthalmol. 1988 Apr;106(4):471-9. doi: 10.1001/archopht.1988.01060130517027.

  PMID: 2895630 BACKGROUND

• McNamara JA, Tasman W, Brown GC, Federman JL. Laser photocoagulation for stage 3+ retinopathy of prematurity. Ophthalmology. 1991 May;98(5):576-80. doi: 10.1016/s0161-6420(91)32247-4.

  PMID: 2062488 BACKGROUND

• Hunter DG, Repka MX. Diode laser photocoagulation for threshold retinopathy of prematurity. A randomized study. Ophthalmology. 1993 Feb;100(2):238-44. doi: 10.1016/s0161-6420(93)31664-7.

  PMID: 8437833 BACKGROUND

• Iverson DA, Trese MT, Orgel IK, Williams GA. Laser photocoagulation for threshold retinopathy of prematurity. Arch Ophthalmol. 1991 Oct;109(10):1342-3. doi: 10.1001/archopht.1991.01080100022007. No abstract available.

  PMID: 1929909 BACKGROUND

• Mintz-Hittner HA, Kennedy KA, Chuang AZ; BEAT-ROP Cooperative Group. Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity. N Engl J Med. 2011 Feb 17;364(7):603-15. doi: 10.1056/NEJMoa1007374.

  PMID: 21323540 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

• Bakri SJ, Snyder MR, Reid JM, Pulido JS, Ezzat MK, Singh RJ. Pharmacokinetics of intravitreal ranibizumab (Lucentis). Ophthalmology. 2007 Dec;114(12):2179-82. doi: 10.1016/j.ophtha.2007.09.012.

  PMID: 18054637 BACKGROUND

• Krohne TU, Liu Z, Holz FG, Meyer CH. Intraocular pharmacokinetics of ranibizumab following a single intravitreal injection in humans. Am J Ophthalmol. 2012 Oct;154(4):682-686.e2. doi: 10.1016/j.ajo.2012.03.047. Epub 2012 Jul 19.

  PMID: 22818800 BACKGROUND

• Bakri SJ, Snyder MR, Reid JM, Pulido JS, Singh RJ. Pharmacokinetics of intravitreal bevacizumab (Avastin). Ophthalmology. 2007 May;114(5):855-9. doi: 10.1016/j.ophtha.2007.01.017.

  PMID: 17467524 BACKGROUND

• Mireskandari K, Adams GG, Tehrani NN. Recurrence of retinopathy of prematurity following bevacizumab monotherapy: is it only the tip of the iceberg? JAMA Ophthalmol. 2013 Apr;131(4):544-5. doi: 10.1001/jamaophthalmol.2013.711. No abstract available.

  PMID: 23579608 BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

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

Study Officials

• Rania MR Bassiouny, MD

  Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 4, 2020
• Study Start: June 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-08

Locations

EG (1)