Drug design, development and therapy · 2026
Anti-Vascular Endothelial Growth Factor Combined with Dexamethasone Implant Therapy for Macular Edema: A Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Ma Yunxi, Wang Junwen, Yuan Mingzhu, Zeng Zimeng, Tan Yuhe, Cao Lu, Sun Xufang
Аннотация
PURPOSE: To compare the efficacy and safety of intravitreal conbercept monotherapy versus conbercept combined with dexamethasone implant in eyes with macular edema (ME).
METHODS: Patients diagnosed with ME secondary to diabetic retinopathy or retinal vein occlusion were enrolled and randomized 1:1 to the combined or monotherapy group. In initial 12 weeks, the combined group received 1 loading dose of conbercept concomitantly with dexamethasone implant (DEX), while the monotherapy group received 3 monthly loading doses of conbercept. Following initial phases, all patients received intravitreal injections of conbercept on demand, assessed every 4 weeks over a 48-week follow-up period. The primary outcome measure was changes in best-corrected visual acuity (BCVA). Secondary outcome measures encompassed changes in optical coherence tomography (OCT) biomarkers and the total number of injections administered. Clinical safety was evaluated based on the incidence and severity of adverse events.
RESULTS: 70 patients (70 eyes) were randomized to monotherapy (n=36) or combination therapy (n=34). Mean (SD) baseline BCVA and CMT were 44.60 (7.34) letters and 555.55 (150.87) μm in monotherapy group; 37.61 (13.47) letters and 581.80 (145.87) μm in combined group. The combined group showed greater BCVA improvement by week 8 and CMT reduction at weeks 4 and 8, and OCT biomarkers also improved more substantially during the first 12 weeks. The combination therapy required significantly fewer injections (P < 0.001) overall but a higher incidence of ocular hypertension. Outcomes of BCVA and CMT correlated with Hard Exudate (HE).
CONCLUSION: Conbercept combined with DEX is an efficient and safe treatment for ME by providing accelerated visual and anatomical improvements in short term and maintaining similar long-term efficacy with fewer injections compared to conbercept monotherapy. OCT biomarkers display prognostic value. HE is associated with poor visual prognosis.
METHODS: Patients diagnosed with ME secondary to diabetic retinopathy or retinal vein occlusion were enrolled and randomized 1:1 to the combined or monotherapy group. In initial 12 weeks, the combined group received 1 loading dose of conbercept concomitantly with dexamethasone implant (DEX), while the monotherapy group received 3 monthly loading doses of conbercept. Following initial phases, all patients received intravitreal injections of conbercept on demand, assessed every 4 weeks over a 48-week follow-up period. The primary outcome measure was changes in best-corrected visual acuity (BCVA). Secondary outcome measures encompassed changes in optical coherence tomography (OCT) biomarkers and the total number of injections administered. Clinical safety was evaluated based on the incidence and severity of adverse events.
RESULTS: 70 patients (70 eyes) were randomized to monotherapy (n=36) or combination therapy (n=34). Mean (SD) baseline BCVA and CMT were 44.60 (7.34) letters and 555.55 (150.87) μm in monotherapy group; 37.61 (13.47) letters and 581.80 (145.87) μm in combined group. The combined group showed greater BCVA improvement by week 8 and CMT reduction at weeks 4 and 8, and OCT biomarkers also improved more substantially during the first 12 weeks. The combination therapy required significantly fewer injections (P < 0.001) overall but a higher incidence of ocular hypertension. Outcomes of BCVA and CMT correlated with Hard Exudate (HE).
CONCLUSION: Conbercept combined with DEX is an efficient and safe treatment for ME by providing accelerated visual and anatomical improvements in short term and maintaining similar long-term efficacy with fewer injections compared to conbercept monotherapy. OCT biomarkers display prognostic value. HE is associated with poor visual prognosis.