Analysis of the Recurrence of Plus Disease after Intravitreal Ranibizumab as a Primary Monotherapy for Severe Retinopathy of Prematurity

Arámbulo, Odalis; Dib, Gabriel; Iturralde, Juan C.; Brito, Miguel; Filho, João Borges Fortes

doi:10.1016/j.oret.2017.11.012

Cited by 13 publications

(16 citation statements)

References 32 publications

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“…[ 35 ] However, various studies on IVI in infants with ROP have reported the safety of injection at 1 mm, 1.5 mm as well as 2 mm from the limbus. [ 10 15 36 37 ] The current survey shows 51.1% of respondents injecting IVI at 1 mm from the limbus, and a nearly equal number (41.9%) injecting at 1.5 mm from the limbus.…”

Section: Discussionmentioning

confidence: 76%

“…[ 11 33 ] However, most of the studies have used half the adult dose. [ 15 31 32 34 ] In the current survey, 113 (77.9%) respondents used half the adult dose for the procedure, irrespective of the agent used, while 30 (20.7%) respondents used one-third or less of the adult dose. Even lower doses require fractioning or special types of equipment which are not accessible to most ROP specialists.…”

Section: Discussionmentioning

confidence: 77%

“…[ 12 ] Delayed recurrence of retinopathy has been documented with anti-VEGF in ROP, making a long-term follow-up essential. [ 13 14 15 ] Suppression of systemic VEGF following intravitreal anti-VEGF injection may have a deleterious effect on the development of other organs including the nervous system of the preterm infant. [ 14 ] Furthermore, there are no established national or international guidelines and protocols regarding use, dosage, or follow-up regimen after the use of anti-VEGF in ROP.…”

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confidence: 99%

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Anti-vascular endothelial growth factor in the management of retinopathy of prematurity: A survey among the members of Indian Retinopathy of Prematurity Society

Gangwe

Agrawal

Vinekar

et al. 2021

Indian Journal of Ophthalmology

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Purpose: To report the results of the survey for the role of anti-VEGF in the management of retinopathy of prematurity (ROP) among the members of Indian ROP (iROP) society. Methods: A questionnaire was designed in English using Google forms and its link was circulated to the members of the iROP society on their mobile numbers. The survey included questions pertaining to demographics, anti-VEGF agents, injection technique, post-injection follow-up, and documentation pertaining to their ROP practice. Anonymous responses were obtained and analyzed for individual questions. Results: 226 members of the society were contacted and 157 responded (69.4%) to the survey. 137 (87.2%) respondents used anti-VEGF in the management of ROP. Aggressive posterior ROP (APROP) was the most common indication (78, 52.7%). The procedure was carried out in the main operation room (102, 70.3%) simultaneously for both the eyes (97; 68%) under topical anesthesia (134; 86.4%) by most of the respondents. One-hundred thirteen (77.9%) respondents used half of the adult dose, irrespective of the agent used; however, more than half of them preferred bevacizumab (85, 54%). 53 (36.3%) respondents followed up infants as per disease severity rather than a fixed schedule while only 33 (23%) performed photo documentation. 151 (96.2%) respondents felt the need for guidelines regarding the usage of anti-VEGF in ROP. Conclusion: There is an increase in the trend towards the use of anti-VEGF in the management of severe ROP, particularly APROP. However, there are considerable variations among the ROP practitioners regarding the agent, dosage, follow-up schedule, and documentation, suggesting the need for uniform guidelines.

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Section: Discussionmentioning

confidence: 76%

Section: Discussionmentioning

confidence: 77%

mentioning

confidence: 99%

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Anti-vascular endothelial growth factor in the management of retinopathy of prematurity: A survey among the members of Indian Retinopathy of Prematurity Society

Gangwe

Agrawal

Vinekar

et al. 2021

Indian Journal of Ophthalmology

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“…Six weeks was taken as the benchmark for deferred laser, as most cases of recurrence or reactivation after initial IVR tend to occur after 6 weeks. [ 13 14 15 ] The infants in group 2 were Followed up weekly to monitor the growth of retinal vessels and recurrence of plus disease or appearance of peripheral retinopathy. The laser was done using Diode laser indirect ophthalmoscope (Iridex ® Germany) under topical anesthesia in NICU after obtaining written informed consent from the parents.…”

Section: Methodsmentioning

confidence: 99%

“…[ 10 11 12 ] Unfavorable structural outcomes and late recurrence of disease and thus need for longer follow-up are common issues with anti-VEGF monotherapy. [ 10 13 14 15 ] To overcome the disadvantages of conventional laser as well as anti-VEGF monotherapy, combined treatment has been evaluated in infants with Zones I and II ROP, which showed promising anatomical outcomes. [ 12 ] Similarly, outcomes of rescue laser after initial treatment with anti-VEGF therapy had also shown good results in APROP.…”

mentioning

confidence: 99%

Outcomes of early versus deferred laser after intravitreal ranibizumab in aggressive posterior retinopathy of prematurity

Gangwe¹,

Agrawal

Gangrade³

et al. 2021

Indian Journal of Ophthalmology

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Purpose: The aim of this study was to report the treatment outcomes of early and deferred laser in infants of aggressive posterior retinopathy of prematurity (APROP) after initial treatment with intravitreal Ranibizumab (IVR). Methods: In a prospective, randomized, interventional study, infants with APROP received IVR (0.25 mg) and were randomized into two groups prior to laser. Laser was done at 1 week (group 1) or at 6 weeks or earlier if there was a recurrence of plus disease (group 2). The structural outcome, number of laser spots, duration of laser procedure and refractive error at 6 months were compared. Favorable structural outcome was defined as, complete regression of disease at 6 weeks after laser. Results: 63 eyes of 32 infants with APROP were enrolled. Mean gestational age (GA) and birth weight (BW) were 30.2 ± 2.3 weeks and 1294 ± 372.8 grams respectively. GA, BW, and disease severity were comparable at baseline. 27 (90%) eyes in group 1 and 29 (93.5%) eyes in group 2 had favorable structural outcome ( P = 0.61) at 6 weeks after laser. Eyes in group 2 (2149.8 ± 688.7) required lesser number of laser spots than group 1 (2570.8 ± 615) ( P = 0.01). At six months, more eyes in group 1 had myopic refractive error (Mean spherical equivalent: –1.0D ± 1.3) than those in group 2 (Mean spherical equivalent: 0.5D ± 1.9) ( P = 0.002). Conclusion: Infants with APROP receiving IVR have comparable structural outcomes after an early or deferred laser. Moreover, eyes undergoing deferred laser require less number of laser spots and have a less myopia at 6 months after laser.

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Plasma Levels of Bevacizumab and Vascular Endothelial Growth Factor After Low-Dose Bevacizumab Treatment for Retinopathy of Prematurity in Infants

Jones¹,

Nasrazadani²,

Cranford³

et al. 2022

JAMA Ophthalmol

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IMPORTANCEIntravitreal bevacizumab effectively treats severe retinopathy of prematurity (ROP), but it enters the bloodstream and may reduce serum vascular endothelial growth factor (VEGF), potentially causing detrimental effects on developing organs in the premature infant.OBJECTIVE To evaluate the association of intravitreal bevacizumab with plasma bevacizumab and VEGF concentrations at 2 and 4 weeks after predefined, de-escalating doses of intravitreal bevacizumab were administered to infants with severe ROP. DESIGN, SETTING, AND PARTICIPANTSThis phase 1 dose de-escalation case series study was conducted at 10 US hospitals of ophthalmology institutions from May 21, 2015, to May 7, 2019. Blood samples were collected 2 and 4 weeks after intravitreal bevacizumab injection. Participants included 83 premature infants with type 1 ROP in 1 or both eyes and no previous ROP treatment. Data were analyzed from April 2017 to August 2021.INTERVENTIONS Study eyes received a single bevacizumab injection of 0.250 mg, 0.125 mg, 0.063 mg, 0.031 mg, 0.016 mg, 0.008 mg, 0.004 mg, or 0.002 mg. When the fellow eye required treatment, one dose higher was administered. Total dose administered at baseline was defined as the sum of doses given to each eye within 3 days of initial study-eye injection. MAIN OUTCOMES AND MEASURESPlasma bevacizumab concentration at 2 and 4 weeks after injection and the percentage change in plasma VEGF concentrations from pretreatment levels. RESULTS A total of 83 infants (mean [SD] age, 25 [2] weeks; 48 boys [58%]) were included in this study. Higher doses of bevacizumab administered at baseline were associated with higher plasma bevacizumab concentrations at 2 weeks (ρ, 0.53; 95% CI, 0.31-0.70) and 4 weeks (ρ, 0.44; 95% CI, 0.18-0.64). Plasma VEGF concentrations decreased by 50% or more from pretreatment levels in 40 of 66 infants (61%) at 2 weeks and 31 of 61 infants (51%) at 4 weeks, but no association was observed between the total dose of bevacizumab administered at baseline and percentage change in plasma VEGF concentrations 2 weeks (ρ, −0.04; 95% CI, −0.28 to 0.20) or 4 weeks (ρ, −0.17; 95% CI, −0.41 to 0.08) after injection.CONCLUSIONS AND RELEVANCE Results of this phase 1 dose de-escalation case series study revealed that bevacizumab doses as low as 0.002 mg were associated with reduced plasma VEGF levels for most infants at 2 and 4 weeks after intravitreal administration; however, no association was observed between total bevacizumab dose administered and reductions in plasma VEGF levels from preinjection to 2 weeks or 4 weeks. Additional studies are needed to evaluate the long-term effects of low-dose bevacizumab on neurodevelopment and retinal structure.

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Analysis of the Recurrence of Plus Disease after Intravitreal Ranibizumab as a Primary Monotherapy for Severe Retinopathy of Prematurity

Cited by 13 publications

References 32 publications

Anti-vascular endothelial growth factor in the management of retinopathy of prematurity: A survey among the members of Indian Retinopathy of Prematurity Society

Anti-vascular endothelial growth factor in the management of retinopathy of prematurity: A survey among the members of Indian Retinopathy of Prematurity Society

Outcomes of early versus deferred laser after intravitreal ranibizumab in aggressive posterior retinopathy of prematurity

Plasma Levels of Bevacizumab and Vascular Endothelial Growth Factor After Low-Dose Bevacizumab Treatment for Retinopathy of Prematurity in Infants

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