Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

JRCT ID: jRCT2031200194

Registered date:10/11/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Proliferative diabetic retinopathy
• Date of first enrollment: 13/01/2021
• Target sample size: 50
• Countries of recruitment: Argentina,Japan,Australia,Japan,Brazil,Japan,Canada,Japan,Chile,Japan,China,Japan,India,Japan,Mexico,Japan,Philippines,Japan,Rep Korea,Japan,Russia,Japan,Taiwan,Japan,Turkey,Japan,USA,Japan
• Study type: Interventional
• Intervention(s): Experimental: Brolucizumab Arm (Intra-vitreal injection), Active Comparator: Panretinal photocoagulation laser Arm (laser)

Outcome(s)

• Primary Outcome: Change from Baseline in BCVA, to demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Signed informed consent must be obtained prior to participation
- Able to complete adequate fundus photographs and retinal images
- Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
- DM treatment stable for at least 3 months
- PDR diagnosis with no previous PRP treatment in the study eye

Exclude criteria

- Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
- Presence of diabetic macular edema in the study eye Active infection or inflammation in the study eye
- Uncontrolled glaucoma (IOP greater than 25 mmHg)
- Intravitreal anti-VEGF treatment within 6 months
- Treatment with intraocular corticosteroids
- End stage renal disease requiring dialysis or kidney transplant
- Uncontrolled blood pressure
- Systemic anti-VEGF therapy at any time Other protocol-defined inclusion/exclusion criteria may apply"

Related Information

• Primary Sponsor: Yamada Hiroyuki
• Secondary ID(s): NCT04278417