EFFICACY AND SAFETY OF A TREAT-AND-EXTEND REGIMEN WITH AFLIBERCEPT IN TREATMENT-NAIVE PATIENTS WITH TYPE 3 NEOVASCULARIZATION: A 52-Week, Single-Arm, Multicenter Trial
To evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions. Phase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions...
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| Published in: | Retina (Philadelphia, Pa.) Vol. 40; no. 7; pp. 1234 - 1244 |
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| Main Authors: | , , , , , |
| Format: | Journal Article |
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Retina
01-07-2020
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| Abstract | To evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions.
Phase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters. Primary endpoint: mean change in best-corrected visual acuity from baseline at 52 weeks.
Thirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70]). Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001). The mean foveal and choroidal thickness decreased by 129.1 ± 80.1 µm (P < 0.0001) and 64.3 ± 96.5 (P = 0.0001), respectively. The proportion of patients with intraretinal/subretinal fluid decreased from 28 (87.5%) at baseline to 3 (11.5%) at Week 52 (P < 0.0001). Pigment epithelial detachment and lesion area showed nonsignificant changes over 52 weeks. The mean number of injections was 8.0 ± 2.0. Seven (21.9%) patients experienced treatment-related adverse events and two (6.3%) experienced serious adverse events; one (3.1%) ocular serious adverse event requiring treatment withdrawal, endophthalmitis, and one (3.1%) nonocular spontaneously resolved serious adverse event, palpitations. One (3.1%) patient experienced an APTC ATE: nonfatal stroke not related to trial treatment.
A treat-and-extend regimen of aflibercept improves visual acuity and retinal edema in eyes with Type 3 neovascularization over 52 weeks with good tolerability. |
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| AbstractList | To evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions.
Phase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters. Primary endpoint: mean change in best-corrected visual acuity from baseline at 52 weeks.
Thirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70]). Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001). The mean foveal and choroidal thickness decreased by 129.1 ± 80.1 µm (P < 0.0001) and 64.3 ± 96.5 (P = 0.0001), respectively. The proportion of patients with intraretinal/subretinal fluid decreased from 28 (87.5%) at baseline to 3 (11.5%) at Week 52 (P < 0.0001). Pigment epithelial detachment and lesion area showed nonsignificant changes over 52 weeks. The mean number of injections was 8.0 ± 2.0. Seven (21.9%) patients experienced treatment-related adverse events and two (6.3%) experienced serious adverse events; one (3.1%) ocular serious adverse event requiring treatment withdrawal, endophthalmitis, and one (3.1%) nonocular spontaneously resolved serious adverse event, palpitations. One (3.1%) patient experienced an APTC ATE: nonfatal stroke not related to trial treatment.
A treat-and-extend regimen of aflibercept improves visual acuity and retinal edema in eyes with Type 3 neovascularization over 52 weeks with good tolerability. PURPOSETo evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions. METHODSPhase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters. Primary endpoint: mean change in best-corrected visual acuity from baseline at 52 weeks. RESULTSThirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70]). Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 (P = 0.0001). The mean foveal and choroidal thickness decreased by 129.1 ± 80.1 µm (P < 0.0001) and 64.3 ± 96.5 (P = 0.0001), respectively. The proportion of patients with intraretinal/subretinal fluid decreased from 28 (87.5%) at baseline to 3 (11.5%) at Week 52 (P < 0.0001). Pigment epithelial detachment and lesion area showed nonsignificant changes over 52 weeks. The mean number of injections was 8.0 ± 2.0. Seven (21.9%) patients experienced treatment-related adverse events and two (6.3%) experienced serious adverse events; one (3.1%) ocular serious adverse event requiring treatment withdrawal, endophthalmitis, and one (3.1%) nonocular spontaneously resolved serious adverse event, palpitations. One (3.1%) patient experienced an APTC ATE: nonfatal stroke not related to trial treatment. CONCLUSIONA treat-and-extend regimen of aflibercept improves visual acuity and retinal edema in eyes with Type 3 neovascularization over 52 weeks with good tolerability. Purpose: To evaluate 52-week efficacy and safety of a treat-and-extend regimen of intravitreal aflibercept 2 mg on treatment-naive Type 3 neovascularization lesions. Methods: Phase IV, prospective, open-label, single-arm, multicenter trial including patients with untreated Stage I/II Type 3 neovascularization lesions and baseline best-corrected visual acuity between 78 and 23 Early Treatment Diabetic Retinopathy Study letters. Primary endpoint: mean change in best-corrected visual acuity from baseline at 52 weeks. Results: Thirty-two eyes from 32 patients were included (mean ± SD age: 78.2 ± 7.7 years, 68.8% females, baseline best-corrected visual acuity: 57.9 ± 15.4 [Snellen fraction 20/70]). Best-corrected visual acuity increased by 10.5 ± 15.9 Early Treatment Diabetic Retinopathy Study letters at Week 52 ( P = 0.0001). The mean foveal and choroidal thickness decreased by 129.1 ± 80.1 µ m ( P < 0.0001) and 64.3 ± 96.5 ( P = 0.0001), respectively. The proportion of patients with intraretinal/subretinal fluid decreased from 28 (87.5%) at baseline to 3 (11.5%) at Week 52 ( P < 0.0001). Pigment epithelial detachment and lesion area showed nonsignificant changes over 52 weeks. The mean number of injections was 8.0 ± 2.0. Seven (21.9%) patients experienced treatment-related adverse events and two (6.3%) experienced serious adverse events; one (3.1%) ocular serious adverse event requiring treatment withdrawal, endophthalmitis, and one (3.1%) nonocular spontaneously resolved serious adverse event, palpitations. One (3.1%) patient experienced an APTC ATE: nonfatal stroke not related to trial treatment. Conclusion: A treat-and-extend regimen of aflibercept improves visual acuity and retinal edema in eyes with Type 3 neovascularization over 52 weeks with good tolerability. |
| Author | Escobar, José Juan Escobar, Antonio Gómez Arias, Luis Cervera, Enrique Zapata, Miguel Ángel Vilimelis, Jaume Crespí |
| AuthorAffiliation | Department of Ophthalmology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain Department of Ophthalmology, Hospital Dos de Maig, Barcelona, Spain Department of Ophthalmology, Hospital Universitari Vall d'Hebron, Barcelona, Spain Department of Ophthalmology, Hospital Universitari de Bellvitge, Barcelona, Spain Department of Ophthalmology, Hospital General de València, València, Spain Department of Ophthalmology, Hospital Universitario Virgen de la Macarena, Sevilla, Spain; and |
| AuthorAffiliation_xml | – name: Department of Ophthalmology, Hospital Universitari Vall d'Hebron, Barcelona, Spain – name: Department of Ophthalmology, Hospital Universitari de Bellvitge, Barcelona, Spain – name: Department of Ophthalmology, Hospital General de València, València, Spain – name: Department of Ophthalmology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain – name: Department of Ophthalmology, Hospital Universitario Virgen de la Macarena, Sevilla, Spain; and – name: Department of Ophthalmology, Hospital Dos de Maig, Barcelona, Spain |
| Author_xml | – sequence: 1 givenname: Luis surname: Arias fullname: Arias, Luis organization: Department of Ophthalmology, Hospital Universitari de Bellvitge, Barcelona, Spain – sequence: 2 givenname: Enrique surname: Cervera fullname: Cervera, Enrique organization: Department of Ophthalmology, Hospital General de València, València, Spain – sequence: 3 givenname: Jaume Crespí surname: Vilimelis fullname: Vilimelis, Jaume Crespí organization: Department of Ophthalmology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain – sequence: 4 givenname: José Juan surname: Escobar fullname: Escobar, José Juan organization: Department of Ophthalmology, Hospital Dos de Maig, Barcelona, Spain – sequence: 5 givenname: Antonio Gómez surname: Escobar fullname: Escobar, Antonio Gómez organization: Department of Ophthalmology, Hospital Universitario Virgen de la Macarena, Sevilla, Spain; and – sequence: 6 givenname: Miguel Ángel surname: Zapata fullname: Zapata, Miguel Ángel organization: Department of Ophthalmology, Hospital Universitari Vall d'Hebron, Barcelona, Spain |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31259813$$D View this record in MEDLINE/PubMed |
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of retinal angiomatous proliferation publication-title: Acta Ophthalmol doi: 10.1111/j.1755-3768.2010.01952.x contributor: fullname: Kramann – volume: 24 start-page: 1585 year: 2010 ident: R5-20230817 article-title: Incidence of neovascularization in the fellow eye of patients with unilateral retinal angiomatous proliferation publication-title: Eye (Lond) doi: 10.1038/eye.2010.88 contributor: fullname: Campa – volume: 92 start-page: 112 year: 2017 ident: R29-20230817 article-title: Treat-and-extend approach with aflibercept: effects on different subtypes of age-related choroidal neovascularisation publication-title: Arch Soc Espanola Oftalmol doi: 10.1016/j.oftal.2016.09.005 contributor: fullname: Castro-Navarro – volume: 100 start-page: 1341 year: 2016 ident: R35-20230817 article-title: Changing from a pro re nata treatment regimen to a treat and extend regimen with ranibizumab in neovascular age-related macular degeneration publication-title: Br J Ophthalmol doi: 10.1136/bjophthalmol-2015-307299 contributor: fullname: Hatz – volume: 246 start-page: 515 year: 2008 ident: R9-20230817 article-title: Choroidal circulatory disturbances associated with retinal angiomatous proliferation on indocyanine green angiography publication-title: Graefes Arch Clin Exp Ophthalmol doi: 10.1007/s00417-007-0705-3 contributor: fullname: Koizumi – volume: 15 start-page: 182 year: 2015 ident: R13-20230817 article-title: One year results of intravitreal ranibizumab monotherapy for retinal angiomatous proliferation: a comparative analysis based on disease stages publication-title: BMC Ophthalmol doi: 10.1186/s12886-015-0172-2 contributor: fullname: Park – volume: 39 start-page: 906 year: 2018 ident: R42-20230817 article-title: MACULAR atrophy incidence in anti-vascular endothelial growth factor-treated neovascular age-related macular degeneration: risk factor evaluation for individualized treatment need of ranibizumab or aflibercept according to an observe-and-plan regimen publication-title: Retina doi: 10.1097/IAE.0000000000002054 contributor: fullname: Mantel – volume: 62 start-page: 462 year: 2017 ident: R16-20230817 article-title: Retinal angiomatous proliferation publication-title: Surv Ophthalmol doi: 10.1016/j.survophthal.2017.01.008 contributor: fullname: Tsai – volume: 4 start-page: 1380 year: 2015 ident: R26-20230817 article-title: Long-term visual outcomes for a treat and extend anti-vascular endothelial growth factor regimen in eyes with neovascular age-related macular degeneration publication-title: J Clin Med doi: 10.3390/jcm4071380 contributor: fullname: Mrejen – volume: 123 start-page: 617 year: 2016 ident: R40-20230817 article-title: Subfoveal choroidal thickness during aflibercept therapy for neovascular age-related macular degeneration publication-title: Ophthalmology doi: 10.1016/j.ophtha.2015.10.039 contributor: fullname: Koizumi – volume: 99 start-page: 11393 year: 2002 ident: R20-20230817 article-title: VEGF-Trap: a VEGF blocker with potent antitumor effects publication-title: Proc Natl Acad Sci USA doi: 10.1073/pnas.172398299 contributor: fullname: Holash – volume: 32 start-page: 376 year: 2016 ident: R38-20230817 article-title: Factors predictive of visual outcome 1 year after intravitreal aflibercept injection for typical neovascular age-related macular degeneration publication-title: J Ocul Pharmacol Ther doi: 10.1089/jop.2015.0125 contributor: fullname: Kikushima – volume: 245 start-page: 295 year: 2007 ident: R2-20230817 article-title: Clinicopathological findings of retinal angiomatous proliferation publication-title: Graefes Arch Clin Exp Ophthalmol doi: 10.1007/s00417-006-0367-6 contributor: fullname: Shimada – volume: 38 start-page: 1968 year: 2018 ident: R8-20230817 article-title: Reduced choriocapillaris flow in eyes with type 3 neovascularization and age-related macular degeneration publication-title: Retina doi: 10.1097/IAE.0000000000002198 contributor: fullname: Borrelli – volume: 121 start-page: 150 year: 2014 ident: R44-20230817 article-title: Risk of geographic atrophy in the comparison of age-related macular degeneration treatments trials publication-title: Ophthalmology doi: 10.1016/j.ophtha.2013.08.015 contributor: fullname: Grunwald – volume: 144 start-page: 449 year: 2007 ident: R15-20230817 article-title: Intravitreal bevacizumab for the treatment of retinal angiomatous proliferation publication-title: Am J Ophthalmol doi: 10.1016/j.ajo.2007.05.025 contributor: fullname: Costagliola |
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| Title | EFFICACY AND SAFETY OF A TREAT-AND-EXTEND REGIMEN WITH AFLIBERCEPT IN TREATMENT-NAIVE PATIENTS WITH TYPE 3 NEOVASCULARIZATION: A 52-Week, Single-Arm, Multicenter Trial |
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