Intravitreal Ranibizumab in Recurrent ROP

Retinopathy of Prematurity Clinical Trial

Official title:

Clinical Outcome Following Reinjection of Ranibizumab in Recurrent Cases With Retinopathy of Prematurity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04539106
• Other study ID #: intravitreal Ranibizumab reinj
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: February 1, 2020

Study information

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

Clinical Trial 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.

Description:

Retinopathy of prematurity was diagnosed and classified according to the International Classification of ROP. Data of the patients who received IVR for type 1 ROP or aggressive posterior ROP (AP-ROP) according to early treatment ROP study (ETROP) were collected. Intravitreal ranibizumab injection was performed as follows; topical anesthetic drop was applied, standard aseptic eye preparation with 5% betadine was performed, a lid speculum was inserted and intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus was given. In case of bilateral ROP, both eyes are injected in the same session. Infants were examined a day after the procedure and weekly thereafter until full vascularization of the retina was observed.

ROP reactivation was defined as any of the following: recurrent plus disease, recurrent neovascularization, or reformation of ridge despite treatment . Once recurrence was determined, second injection of IVR (0.25mg/0.025mL) was given to patients or surgery was performed if progressed to stage 4 or 5. All treated infants were examined until complete regression of ROP and full retinal vascularization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

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

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 (13)

Bakri SJ, Snyder MR, Reid JM, Pulido JS, Ezzat MK, Singh RJ. Pharmacokinetics of intravitreal ranibizumab (Lucentis). Ophthalmology. 2007 Dec;114(12):2179-82. — View Citation

Bakri SJ, Snyder MR, Reid JM, Pulido JS, Singh RJ. Pharmacokinetics of intravitreal bevacizumab (Avastin). Ophthalmology. 2007 May;114(5):855-9. — View Citation

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. Review. — View Citation

Hunter DG, Repka MX. Diode laser photocoagulation for threshold retinopathy of prematurity. A randomized study. Ophthalmology. 1993 Feb;100(2):238-44. — View Citation

Iverson DA, Trese MT, Orgel IK, Williams GA. Laser photocoagulation for threshold retinopathy of prematurity. Arch Ophthalmol. 1991 Oct;109(10):1342-3. — View Citation

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. — View Citation

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. — View Citation

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. — 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

McNamara JA, Tasman W, Brown GC, Federman JL. Laser photocoagulation for stage 3+ retinopathy of prematurity. Ophthalmology. 1991 May;98(5):576-80. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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