Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04278417
Recruitment Status : Recruiting
First Posted : February 20, 2020
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy Biological: Brolucizumab 6 mg Procedure: Panretinal photocoagulation laser Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
Actual Study Start Date : November 19, 2020
Estimated Primary Completion Date : November 29, 2024
Estimated Study Completion Date : January 10, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brolucizumab Arm
Intra-vitreal injection
Biological: Brolucizumab 6 mg
3 x q6w loading injections, followed by q12w maintenance through Week 90
Other Name: RTH258

Active Comparator: Panretinal photocoagulation laser Arm
laser
Procedure: Panretinal photocoagulation laser
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
Other Name: PRP




Primary Outcome Measures :
  1. Change from Baseline in BCVA [ Time Frame: At Week 54 ]
    To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54


Secondary Outcome Measures :
  1. Proportion of subjects with no PDR at Week 54 [ Time Frame: At Week 54 ]
    To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at Week 54

  2. Proportion of subjects with center-involved DME up to Week 54 [ Time Frame: At Week 54 ]
    To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to Week 54

  3. Area under the curve in change from Baseline in BCVA up to Week 54 and Week 96 [ Time Frame: From Baseline in BCVA up to Week 54 and Week 96 ]
    To compare the effect of brolucizumab relative to PRP with respect to visual acuity

  4. Change from Baseline in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at Week 54 and Week 96 [ Time Frame: From Baseline score to Week 54 and Week 96 ]
    To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status

  5. Proportion of subjects with no PDR at Week 96 [ Time Frame: At Week 96 ]
    To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status

  6. Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96 [ Time Frame: At Week 54 and Week 96 ]
    To compare the effect of brolucizumab relative to PRP on ocular complications

  7. Proportion of subjects with center-involved DME up to Week 96 [ Time Frame: At Week 96 ]
    To compare the effect of brolucizumab relative to PRP on ocular complications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
  2. 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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04278417


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Show Show 117 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04278417    
Other Study ID Numbers: CRTH258D2301
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases