601A / 3SBio - LARVOL DELTA

SSGJ-601 versus Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion: 52-Week Results from a Phase 3 Study. (PubMed, Ophthalmol Retina) - "This study supports the conclusion of no clinical meaningful differences in efficacy, safety, and immunogenicity between SSGJ-601 and ranibizumab in patients with macular edema secondary to BRVO. Additionally, treatment transitioned to a pro re nata (PRN) schedule based on investigator-assessed retreatment criteria resulted in sustained benefits in visual and anatomical outcomes."

Journal • P3 data • Diabetic Retinopathy • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss (clinicaltrials.gov) - P3 | N=351 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Recruiting ➔ Completed

Trial completion • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

601 Versus Ranibizumab in Patients With Branch Retinal Vein Occlusion (BRVO) (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO) (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss (clinicaltrials.gov) - P3 | N=350 | Recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2025 ➔ Dec 2025 | Initiation date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion

A Phase III Study for 601 Versus Ranibizumab in Patients With Branch Retinal Vein Occlusion (BRVO) (clinicaltrials.gov) - P3 | N=350 | Not yet recruiting | Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

New P3 trial • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion