Conbercept for Treatment of Neovascular Age-related Macular Degeneration: Results of the Randomized Phase 3 PHOENIX Study

PHOENIX Study Group

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose: Age-related macular degeneration (AMD) can cause irreversible vision loss leading to blindness. We aim to evaluate the efficacy and safety of intravitreal injections of 0.5 mg conbercept, a new anti–vascular endothelial growth factor (anti-VEGF) drug, for treatment of AMD on a schedule more manageable for patients. Design: A prospective, double-masked, multicenter, sham-controlled, phase III randomized trial. Methods: PATIENTS: Patients with choroidal neovascularization (CNV) secondary to AMD were enrolled and randomized to the conbercept group or the sham control group. INTERVENTION: The conbercept group received intravitreal injections of conbercept (0.5 mg) once monthly for the first 3 months, then once quarterly until month 12 (3 + Q3M). The sham group received first 3 monthly sham injections and then 3 monthly injections of conbercept (0.5 mg) followed by quarterly administrations until month 12. MAIN OUTCOME MEASURES: The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 3. Results: A total of 114 patients (91.9%) from 9 sites in China completed the 12-month study. At the 3-month primary endpoint, the mean changes in BCVA from baseline were +9.20 letters in the conbercept group and +2.02 letters in the sham group, respectively (P <.001). At 12 months, the mean changes from baseline in BCVA letter score were +9.98 letters in the conbercept group and +8.81 letters in the sham group (P =.64). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival hemorrhage, and increased intraocular pressure. Conclusions: A conbercept dosing regimen of 3 initial monthly administrations followed by quarterly treatments is effective for treatment of AMD. In previous reports, other anti-VEGF agents were unable to maintain similar clinical benefits with the same regimen.

Original languageEnglish (US)
Pages (from-to)156-167
Number of pages12
JournalAmerican journal of ophthalmology
Volume197
DOIs
StatePublished - Jan 1 2019

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Macular Degeneration
Intravitreal Injections
Endothelial Growth Factors
Visual Acuity
Therapeutics
Choroidal Neovascularization
Injections
KH902 fusion protein
Blindness
Intraocular Pressure
China
Appointments and Schedules
Hemorrhage
Safety
Control Groups
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Ophthalmology

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Conbercept for Treatment of Neovascular Age-related Macular Degeneration : Results of the Randomized Phase 3 PHOENIX Study. / PHOENIX Study Group.

In: American journal of ophthalmology, Vol. 197, 01.01.2019, p. 156-167.

Research output: Contribution to journalArticle

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title = "Conbercept for Treatment of Neovascular Age-related Macular Degeneration: Results of the Randomized Phase 3 PHOENIX Study",
abstract = "Purpose: Age-related macular degeneration (AMD) can cause irreversible vision loss leading to blindness. We aim to evaluate the efficacy and safety of intravitreal injections of 0.5 mg conbercept, a new anti–vascular endothelial growth factor (anti-VEGF) drug, for treatment of AMD on a schedule more manageable for patients. Design: A prospective, double-masked, multicenter, sham-controlled, phase III randomized trial. Methods: PATIENTS: Patients with choroidal neovascularization (CNV) secondary to AMD were enrolled and randomized to the conbercept group or the sham control group. INTERVENTION: The conbercept group received intravitreal injections of conbercept (0.5 mg) once monthly for the first 3 months, then once quarterly until month 12 (3 + Q3M). The sham group received first 3 monthly sham injections and then 3 monthly injections of conbercept (0.5 mg) followed by quarterly administrations until month 12. MAIN OUTCOME MEASURES: The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 3. Results: A total of 114 patients (91.9{\%}) from 9 sites in China completed the 12-month study. At the 3-month primary endpoint, the mean changes in BCVA from baseline were +9.20 letters in the conbercept group and +2.02 letters in the sham group, respectively (P <.001). At 12 months, the mean changes from baseline in BCVA letter score were +9.98 letters in the conbercept group and +8.81 letters in the sham group (P =.64). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival hemorrhage, and increased intraocular pressure. Conclusions: A conbercept dosing regimen of 3 initial monthly administrations followed by quarterly treatments is effective for treatment of AMD. In previous reports, other anti-VEGF agents were unable to maintain similar clinical benefits with the same regimen.",
author = "{PHOENIX Study Group} and Kun Liu and Yanping Song and Gezhi Xu and Jian Ye and Zhifeng Wu and Xiaoling Liu and Xiaoguang Dong and Mingzhi Zhang and Yiqiao Xing and Shaoping Zhu and Xia Chen and Yinchen Shen and Hengye Huang and Liyun Yu and Zunhong Ke and Rosenfeld, {Philip J} and Kaiser, {Peter K.} and Guishuang Ying and Xiaodong Sun and Xun Xu and Rong Li and Quan Wu and Xinguo Wang and Fenglei Kuang and Jing Lv and Zhili Niu",
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T1 - Conbercept for Treatment of Neovascular Age-related Macular Degeneration

T2 - Results of the Randomized Phase 3 PHOENIX Study

AU - PHOENIX Study Group

AU - Liu, Kun

AU - Song, Yanping

AU - Xu, Gezhi

AU - Ye, Jian

AU - Wu, Zhifeng

AU - Liu, Xiaoling

AU - Dong, Xiaoguang

AU - Zhang, Mingzhi

AU - Xing, Yiqiao

AU - Zhu, Shaoping

AU - Chen, Xia

AU - Shen, Yinchen

AU - Huang, Hengye

AU - Yu, Liyun

AU - Ke, Zunhong

AU - Rosenfeld, Philip J

AU - Kaiser, Peter K.

AU - Ying, Guishuang

AU - Sun, Xiaodong

AU - Xu, Xun

AU - Li, Rong

AU - Wu, Quan

AU - Wang, Xinguo

AU - Kuang, Fenglei

AU - Lv, Jing

AU - Niu, Zhili

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Purpose: Age-related macular degeneration (AMD) can cause irreversible vision loss leading to blindness. We aim to evaluate the efficacy and safety of intravitreal injections of 0.5 mg conbercept, a new anti–vascular endothelial growth factor (anti-VEGF) drug, for treatment of AMD on a schedule more manageable for patients. Design: A prospective, double-masked, multicenter, sham-controlled, phase III randomized trial. Methods: PATIENTS: Patients with choroidal neovascularization (CNV) secondary to AMD were enrolled and randomized to the conbercept group or the sham control group. INTERVENTION: The conbercept group received intravitreal injections of conbercept (0.5 mg) once monthly for the first 3 months, then once quarterly until month 12 (3 + Q3M). The sham group received first 3 monthly sham injections and then 3 monthly injections of conbercept (0.5 mg) followed by quarterly administrations until month 12. MAIN OUTCOME MEASURES: The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 3. Results: A total of 114 patients (91.9%) from 9 sites in China completed the 12-month study. At the 3-month primary endpoint, the mean changes in BCVA from baseline were +9.20 letters in the conbercept group and +2.02 letters in the sham group, respectively (P <.001). At 12 months, the mean changes from baseline in BCVA letter score were +9.98 letters in the conbercept group and +8.81 letters in the sham group (P =.64). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival hemorrhage, and increased intraocular pressure. Conclusions: A conbercept dosing regimen of 3 initial monthly administrations followed by quarterly treatments is effective for treatment of AMD. In previous reports, other anti-VEGF agents were unable to maintain similar clinical benefits with the same regimen.

AB - Purpose: Age-related macular degeneration (AMD) can cause irreversible vision loss leading to blindness. We aim to evaluate the efficacy and safety of intravitreal injections of 0.5 mg conbercept, a new anti–vascular endothelial growth factor (anti-VEGF) drug, for treatment of AMD on a schedule more manageable for patients. Design: A prospective, double-masked, multicenter, sham-controlled, phase III randomized trial. Methods: PATIENTS: Patients with choroidal neovascularization (CNV) secondary to AMD were enrolled and randomized to the conbercept group or the sham control group. INTERVENTION: The conbercept group received intravitreal injections of conbercept (0.5 mg) once monthly for the first 3 months, then once quarterly until month 12 (3 + Q3M). The sham group received first 3 monthly sham injections and then 3 monthly injections of conbercept (0.5 mg) followed by quarterly administrations until month 12. MAIN OUTCOME MEASURES: The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA) at month 3. Results: A total of 114 patients (91.9%) from 9 sites in China completed the 12-month study. At the 3-month primary endpoint, the mean changes in BCVA from baseline were +9.20 letters in the conbercept group and +2.02 letters in the sham group, respectively (P <.001). At 12 months, the mean changes from baseline in BCVA letter score were +9.98 letters in the conbercept group and +8.81 letters in the sham group (P =.64). The most common ocular adverse events were associated with intravitreal injections, such as conjunctival hemorrhage, and increased intraocular pressure. Conclusions: A conbercept dosing regimen of 3 initial monthly administrations followed by quarterly treatments is effective for treatment of AMD. In previous reports, other anti-VEGF agents were unable to maintain similar clinical benefits with the same regimen.

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