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

  • STATUS
    Recruiting
  • End date
    Jan 10, 2025
  • participants needed
    706
  • sponsor
    Novartis Pharmaceuticals
Updated on 9 May 2021

Summary

The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Details
Condition Proliferative Diabetic Retinopathy
Treatment Brolucizumab 6 mg, Panretinal photocoagulation laser
Clinical Study IdentifierNCT04278417
SponsorNovartis Pharmaceuticals
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Proliferative Diabetic Retinopathy??
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

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
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 -
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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