MedDataX Logo

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

NCT ID: NCT04278417

Last Updated: 2025-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

689 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-19

Study Completion Date

2024-08-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study was 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Assessing the Efficacy and Safety of a Personalized Monotherapy Regimen of Brolucizumab in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy

NCT05666804

Macular Polypoidal Choroidal Vasculopathy (PCV)
COMPLETED PHASE3

PRP vs Bevacizumab for PDR Treatment

NCT02705274

Proliferative Diabetic Retinopathy
COMPLETED PHASE2/PHASE3

Retrospective Review of Proliferative Diabetic Retinopathy Patients

NCT03609996

Proliferative Diabetic Retinopathy
UNKNOWN

Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy

NCT01746563

Diabetic Retinopathy Retinal Diseases Eye Diseases +3 more
COMPLETED PHASE1/PHASE2

Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy.

NCT01941329

High Risk Proliferative Diabetic Retinopathy
COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR).

Subjects who consented underwent screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria. Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments:

Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks, and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.

PRP: initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment (may split into 2-4 sessions) as needed up to Week 90.

Visits occurred every 6 weeks throughout the study, regardless of treatment or not.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Proliferative Diabetic Retinopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Brolucizumab 6 mg

Intra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90

Group Type EXPERIMENTAL

Brolucizumab 6 mg

Intervention Type BIOLOGICAL

3 x q6w loading injections, followed by q12w maintenance through Week 90

Panretinal photocoagulation laser Arm

Initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Group Type ACTIVE_COMPARATOR

Panretinal photocoagulation laser

Intervention Type PROCEDURE

initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Brolucizumab 6 mg

3 x q6w loading injections, followed by q12w maintenance through Week 90

Intervention Type BIOLOGICAL

Panretinal photocoagulation laser

initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RTH258 PRP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Retina Associates SW

Tucson, Arizona, United States

Site Status

Retina- Vitreous Assoc Medical Group

Beverly Hills, California, United States

Site Status

Retina Consultants of Orange County

Fullerton, California, United States

Site Status

Salehi Retina Institute

Huntington Beach, California, United States

Site Status

Retina Consultants of Southern California

Redlands, California, United States

Site Status

Premiere Practice Management LLC

Torrance, California, United States

Site Status

Lundquist Inst BioMed at Harbor

Torrance, California, United States

Site Status

Miramar Eye Specialists

Ventura, California, United States

Site Status

Advanced Research LLC

Deerfield Beach, Florida, United States

Site Status

Rand Eye Institute

Deerfield Beach, Florida, United States

Site Status

Pinnacle Research Institute

Fort Lauderdale, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

Florida Retina Institute

Jacksonville, Florida, United States

Site Status

Blue Oc Clin Res at Palm Bch Eye Ct

Lakeland, Florida, United States

Site Status

MedEye Associates

Miami, Florida, United States

Site Status

Florida Retina Institute

Orlando, Florida, United States

Site Status

Eye Center of North Florida

Panama City, Florida, United States

Site Status

Fort Lauderdale Eye Institute

Plantation, Florida, United States

Site Status

Retina Associates

Elmhurst, Illinois, United States

Site Status

Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status

John-Kenyon American Eye Institute PC

New Albany, Indiana, United States

Site Status

Retina Associates PA

Lenexa, Kansas, United States

Site Status

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status

University of Mississippi Med Ctr

Jackson, Mississippi, United States

Site Status

Retina Associates Of Cleveland

Cleveland, Ohio, United States

Site Status

Dean McGee Eye Institute

Oklahoma City, Oklahoma, United States

Site Status

Cascade Medical Research Institute

Springfield, Oregon, United States

Site Status

Erie Retinal Surgery

Erie, Pennsylvania, United States

Site Status

Charleston Neuroscience Institute

Ladson, South Carolina, United States

Site Status

Southeastern Retina Associates P C

Knoxville, Tennessee, United States

Site Status

Austin Retina Associates

Austin, Texas, United States

Site Status

Texan Eye P A

Austin, Texas, United States

Site Status

Retina And Vitreous Of Texas

Bellaire, Texas, United States

Site Status

Retina Consultants TX Rsrch Ctr

Bellaire, Texas, United States

Site Status

Texas Retina Associates

Fort Worth, Texas, United States

Site Status

Valley Retina Institute PA

Harlingen, Texas, United States

Site Status

Retina Consultants of Houston PA

Houston, Texas, United States

Site Status

Medical Center Opthamology Assoc

San Antonio, Texas, United States

Site Status

Retina Associates Of South Texas PA

San Antonio, Texas, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

Novartis Investigative Site

Caba, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Ciudad Autonoma de Bs As, Buenos Aires, Argentina

Site Status

Novartis Investigative Site

Rosario, De Santa Fe, Argentina

Site Status

Novartis Investigative Site

CABA, , Argentina

Site Status

Novartis Investigative Site

Albury, New South Wales, Australia

Site Status

Novartis Investigative Site

Liverpool, New South Wales, Australia

Site Status

Novartis Investigative Site

Parramatta, New South Wales, Australia

Site Status

Novartis Investigative Site

Strathfield, New South Wales, Australia

Site Status

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Novartis Investigative Site

Blumenau, Santa Catarina, Brazil

Site Status

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Site Status

Novartis Investigative Site

Sorocaba, São Paulo, Brazil

Site Status

Novartis Investigative Site

Ottawa, Ontario, Canada

Site Status

Novartis Investigative Site

Toronto, Ontario, Canada

Site Status

Novartis Investigative Site

Boisbriand, Quebec, Canada

Site Status

Novartis Investigative Site

Québec, Quebec, Canada

Site Status

Novartis Investigative Site

Santiago, RM, Chile

Site Status

Novartis Investigative Site

Beijing, Beijing Municipality, China

Site Status

Novartis Investigative Site

Shantou, Guangdong, China

Site Status

Novartis Investigative Site

Wuhan, Hubei, China

Site Status

Novartis Investigative Site

Wuhan, Hubei, China

Site Status

Novartis Investigative Site

Nanjing, Jiangsu, China

Site Status

Novartis Investigative Site

Nantong, Jiangsu, China

Site Status

Novartis Investigative Site

Changchun, Jilin, China

Site Status

Novartis Investigative Site

Shenyang, Liaoning, China

Site Status

Novartis Investigative Site

Xi'an, Shaanxi, China

Site Status

Novartis Investigative Site

Chengdu, Sichuan, China

Site Status

Novartis Investigative Site

Tianjin, Tianjin Municipality, China

Site Status

Novartis Investigative Site

Wenzhou, Zhejiang, China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Beijing, , China

Site Status

Novartis Investigative Site

Shanghai, , China

Site Status

Novartis Investigative Site

Ahmedabad, Gujarat, India

Site Status

Novartis Investigative Site

Coimbatore, Tamil Nadu, India

Site Status

Novartis Investigative Site

Tirunelveli, Tamil Nadu, India

Site Status

Novartis Investigative Site

Chandigarh, , India

Site Status

Novartis Investigative Site

New Delhi, , India

Site Status

Novartis Investigative Site

Nagakute, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Site Status

Novartis Investigative Site

Sakura, Chiba, Japan

Site Status

Novartis Investigative Site

Yoshida-gun, Fukui, Japan

Site Status

Novartis Investigative Site

Kurume, Fukuoka, Japan

Site Status

Novartis Investigative Site

Kōriyama, Fukushima, Japan

Site Status

Novartis Investigative Site

Asahikawa, Hokkaido, Japan

Site Status

Novartis Investigative Site

Kita-gun, Kagawa-ken, Japan

Site Status

Novartis Investigative Site

Tsu, Mie-ken, Japan

Site Status

Novartis Investigative Site

Matsumoto, Nagano, Japan

Site Status

Novartis Investigative Site

Shimotsuke, Tochigi, Japan

Site Status

Novartis Investigative Site

Chiyoda-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Hachiōji, Tokyo, Japan

Site Status

Novartis Investigative Site

Meguro-ku, Tokyo, Japan

Site Status

Novartis Investigative Site

Akita, , Japan

Site Status

Novartis Investigative Site

Kobe, , Japan

Site Status

Novartis Investigative Site

Osaka, , Japan

Site Status

Novartis Investigative Site

Ciudad de, Mexico City, Mexico

Site Status

Novartis Investigative Site

Mexico City, , Mexico

Site Status

Novartis Investigative Site

Tijuana, , Mexico

Site Status

Novartis Investigative Site

Makati, NCR, Philippines

Site Status

Novartis Investigative Site

Makati, , Philippines

Site Status

Novartis Investigative Site

Pasig, , Philippines

Site Status

Emanuelli Research and Development Center LLC

Arecibo, , Puerto Rico

Site Status

Novartis Investigative Site

Cheboksary, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Omsk, , Russia

Site Status

Novartis Investigative Site

Sterlitamak, , Russia

Site Status

Novartis Investigative Site

Ulyanovsk, , Russia

Site Status

Novartis Investigative Site

Yekaterinburg, , Russia

Site Status

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Site Status

Novartis Investigative Site

Seoul, Seocho Gu, South Korea

Site Status

Novartis Investigative Site

Daegu, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Hualien City, , Taiwan

Site Status

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Ankara, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Istanbul, , Turkey (Türkiye)

Site Status

Novartis Investigative Site

Izmir, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Brazil Canada Chile China India Japan Mexico Philippines Puerto Rico Russia South Korea Taiwan Turkey (Türkiye)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=2680

A Plain Language Trial Summary is available on www.novctrd.com

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRTH258D2301

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of Ranibizumab With or Without Laser in Comparison to Laser in Branch Retinal Vein Occlusion
NCT01599650 COMPLETED PHASE3
Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
NCT01489189 COMPLETED PHASE3
Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy
NCT01102946 COMPLETED PHASE2
Efficacy and Safety of RTH258 Versus Aflibercept - Study 2
NCT02434328 COMPLETED PHASE3
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
NCT04722991 COMPLETED PHASE2
Analysis of Imaging Features From Patients Treated With Brolucizumab in the Post-marketing Setting With Reports of Retinal Vasculitis and/or Retinal Vascular Occlusion
NCT05657158 COMPLETED
A Phase 3 Study to Compare the Efficacy and Safety of HLX04-O with Ranibizumab in Subjects with WAMD
NCT04740671 COMPLETED PHASE3
Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy
NCT01280929 COMPLETED PHASE2
Brolucizumab vs. Aflibercept for Retinal Angiomatous Proliferation
NCT04698850 WITHDRAWN PHASE4
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
NCT01217944 COMPLETED PHASE3
Ranibizumab for Polypoidal Choroidal Vasculopathy (PCV)
NCT00424710 COMPLETED PHASE1
A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss
NCT05520177 COMPLETED PHASE3
A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
NCT02484690 COMPLETED PHASE2
Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE)
NCT01594281 COMPLETED PHASE2
Efficacy and Safety of Ranibizumab in Japanese Patients With Retinal Vein Occlusion
NCT01377597 COMPLETED PHASE3
Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO
NCT03054766 COMPLETED NA
Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety
NCT02953938 COMPLETED PHASE4
Retinal Sensitivity in BRVO After Anti-VEGF Therapy
NCT02527733 UNKNOWN PHASE4
Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Retinal Detachment Repair
NCT04580147 UNKNOWN PHASE2
Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
NCT00433017 TERMINATED PHASE2/PHASE3
Regulatory Post-Marketing Surveillance Study for Brolucizumab
NCT04985487 RECRUITING
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
NCT06176352 ACTIVE_NOT_RECRUITING PHASE3
Treatment With Intravitreal Aflibercept Injection For Proliferative Diabetic Retinopathy, The A.C.T Study
NCT01813773 COMPLETED PHASE2/PHASE3
Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
NCT00901186 COMPLETED PHASE2
A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study
NCT00687804 COMPLETED PHASE3