Study of efficacy and safety of brolucizumab versus panretinal photocoagulation laser in patients with proliferative diabetic retinopathy

Phase 3

Completed

Brief Summary: To evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR)

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent must be obtained prior to participation in the study.
Patients olde than or equal to 18 years of age at screening.
Participant cooperation sufficient for adequate fundus photographs and retinal images.
Patients diagnosed with type 1 or 2 DM and HbA1c more than or equal to 12 percent at screening.
Any medication administered for the management od DM should be stable within 3 months prior to randomization and is expected to remain stable during the course of the study, as medically acceptable.
PDR as assesses by the investigator using standard or wide-field CFP and FA with no evidence of previous PRP, and that requires treatment with either anti-VEGF or PRP in the opinion of the investigator.

Exclusion 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 3.
Uncontrolled glaucoma (IOP greater than 25 mmHg) 4.
Intravitreal anti-VEGF treatment within 6 months 5.
Treatment with intraocular corticosteroids 6.
End stage renal disease requiring dialysis or kidney transplant 7.
Uncontrolled blood pressure 8.
Systemic anti-VEGF therapy at any time Other protocol-defined inclusion/exclusion criteria may apply.

Primary Outcome Measures

Name	Time	Method
To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from BAseline in visual acuity at week 54	week 54

Secondary Outcome Measures

Name	Time	Method
To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at week 54	Proportion of subjects with no PDR at week 54
To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to week 54	Proportion of subjects with center-involved DME up to week 54
To compare the effect of brolucizumab relative to PRP with respect to visual acuity	Area under the curve in change from BAseline in BCVA up to week 54 and week 96

Locations (6): All India Institute Of Medical Sciences
🇮🇳
Delhi, DELHI, India
Aravind Eye Hospital
🇮🇳
Coimbatore, TAMIL NADU, India
Dr. Agarwals Eye Hospital
🇮🇳
Tirunelveli, TAMIL NADU, India
Government Eye Hospital, M & J Institute of Ophthalmology
🇮🇳
Ahmadabad, GUJARAT, India
Post Graduate Insitute of Medical Edication and Research
🇮🇳
Chandigarh, CHANDIGARH, India
Shri Mahant Indiresh Hospital
🇮🇳
Dehradun, UTTARANCHAL, India
All India Institute Of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Rajpal Vohra
Principal investigator
9818598899
vohrarajpal@gmail.com