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NCT04278417 Clinical Trial

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

Proliferative Diabetic Retinopathy Clinical Trial

— CONDOR  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04278417
Other study ID # CRTH258D2301
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 19, 2020
Est. completion date August 20, 2024

Study information
Verified date April 2024
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 689
Est. completion date August 20, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Brolucizumab 6 mg
3 x q6w loading injections, followed by q12w maintenance through Week 90
Procedure:
• Panretinal photocoagulation laser
initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Locations
Country Name City State
Argentina Novartis Investigative Site Caba Buenos Aires
Argentina Novartis Investigative Site Caba
Argentina Novartis Investigative Site Ciudad Autonoma de Bs As Buenos Aires
Argentina Novartis Investigative Site Rosario De Santa Fe
Australia Novartis Investigative Site Albury New South Wales
Australia Novartis Investigative Site Liverpool New South Wales
Australia Novartis Investigative Site Parramatta New South Wales
Australia Novartis Investigative Site Strathfield New South Wales
Brazil Novartis Investigative Site Blumenau SC
Brazil Novartis Investigative Site Porto Alegre RS
Brazil Novartis Investigative Site Sao Paulo SP
Brazil Novartis Investigative Site Sorocaba SP
Canada Novartis Investigative Site Boisbriand Quebec
Canada Novartis Investigative Site Ottawa Ontario
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Toronto Ontario
Chile Novartis Investigative Site Santiago RM
China Novartis Investigative Site Beijing Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Beijing
China Novartis Investigative Site Changchun City Jilin
China Novartis Investigative Site Chengdu Sichuan
China Novartis Investigative Site Nanjing City Jiangsu
China Novartis Investigative Site Nantong Jiangsu
China Novartis Investigative Site Shanghai
China Novartis Investigative Site Shantou Guangdong
China Novartis Investigative Site Shenyang City Liaoning
China Novartis Investigative Site Tianjin Tianjin
China Novartis Investigative Site Tianjin Tianjin
China Novartis Investigative Site Wenzhou Zhejiang
China Novartis Investigative Site Wuhan Hubei
China Novartis Investigative Site Wuhan Hubei
China Novartis Investigative Site Xian Shaanxi
India Novartis Investigative Site Ahmedabad Gujarat
India Novartis Investigative Site Chandigarh
India Novartis Investigative Site Coimbatore Tamil Nadu
India Novartis Investigative Site New Delhi
India Novartis Investigative Site Tirunelveli Tamilnadu
Japan Novartis Investigative Site Akita
Japan Novartis Investigative Site Asahikawa-city Hokkaido
Japan Novartis Investigative Site Chiyoda-ku Tokyo
Japan Novartis Investigative Site Hachioji-city Tokyo
Japan Novartis Investigative Site Kita-gun Kagawa
Japan Novartis Investigative Site Kobe-shi Hyogo
Japan Novartis Investigative Site Koriyama Fukushima
Japan Novartis Investigative Site Kurume city Fukuoka
Japan Novartis Investigative Site Matsumoto Nagano
Japan Novartis Investigative Site Meguro-ku Tokyo
Japan Novartis Investigative Site Nagakute-city Aichi
Japan Novartis Investigative Site Nagoya Aichi
Japan Novartis Investigative Site Osaka
Japan Novartis Investigative Site Sakura Chiba
Japan Novartis Investigative Site Shimotsuke Tochigi
Japan Novartis Investigative Site Tsu-city Mie
Japan Novartis Investigative Site Yoshida-gun Fukui
Korea, Republic of Novartis Investigative Site Bundang Gu Gyeonggi Do
Korea, Republic of Novartis Investigative Site Daegu
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul Seocho Gu
Mexico Novartis Investigative Site Ciudad De Mexico Distrito Federal
Mexico Novartis Investigative Site Ciudad de Mexico
Mexico Novartis Investigative Site Tijuana
Philippines Novartis Investigative Site Makati NCR
Philippines Novartis Investigative Site Makati
Philippines Novartis Investigative Site Pasig City
Puerto Rico Emanuelli Research and Development Center LLC Arecibo
Russian Federation Novartis Investigative Site Cheboksary
Russian Federation Novartis Investigative Site Ekaterinburg
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Omsk
Russian Federation Novartis Investigative Site Sterlitamak
Russian Federation Novartis Investigative Site Ulyanovsk
Taiwan Novartis Investigative Site Hualien
Taiwan Novartis Investigative Site Kaohsiung
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Izmir
United States Austin Retina Associates Austin Texas
United States Texan Eye P A Austin Texas
United States Retina And Vitreous Of Texas Ophthalmology 3 Bellaire Texas
United States Retina Consultants TX Rsrch Ctr Bellaire Texas
United States Retina Vitreous Assoc Medical Group . Beverly Hills California
United States Retina Associates Of Cleveland . Cleveland Ohio
United States Advanced Research LLC Coral Springs Florida
United States Rand Eye Institute Deerfield Beach Florida
United States Retina Associates Elmhurst Illinois
United States Erie Retinal Surgery Erie Pennsylvania
United States Novartis Investigative Site Fort Lauderdale Florida
United States National Ophthalmic Research Institute Ophthalmology Fort Myers Florida
United States Texas Retina Associates Fort Worth Texas
United States Retina Consultants of Orange County Fullerton California
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Valley Retina Institute PA . Harlingen Texas
United States Retina Consultants of Houston PA . Houston Texas
United States Salehi Retina Institute Huntington Beach California
United States Midwest Eye Institute . Indianapolis Indiana
United States University of Mississippi Med Ctr . Jackson Mississippi
United States Florida Retina Institute Jacksonville Florida
United States Southeastern Retina Associates P C . Knoxville Tennessee
United States Charleston Neuroscience Institute Ladson South Carolina
United States Novartis Investigative Site Lakeland Florida
United States Retina Associates PA Lenexa Kansas
United States MedEye Associates Ophthalmology Miami Florida
United States John-Kenyon American Eye Institute PC New Albany Indiana
United States Virginia Eye Consultants Norfolk Virginia
United States Dean McGee Eye Institute Oklahoma City Oklahoma
United States Florida Retina Institute Ophthalmology Orlando Florida
United States Eye Center of North Florida Panama City Florida
United States Fort Lauderdale Eye Institute . Plantation Florida
United States Retina Consultants of Southern California . Redlands California
United States Medical Center Opthamology Assoc . San Antonio Texas
United States Retina Associates Of South Texas PA CRFB002H2301 San Antonio Texas
United States Cascade Medical Research Institute Springfield Oregon
United States Lundquist Inst BioMed at Harbor . Torrance California
United States Premiere Practice Management LLC Torrance California
United States Retina Associates SW Tucson Arizona
United States Novartis Investigative Site Ventura California

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Chile,  China,  India,  Japan,  Korea, Republic of,  Mexico,  Philippines,  Puerto Rico,  Russian Federation,  Taiwan,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 At Week 54
Secondary Proportion of subjects with no PDR at Week 54 To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at Week 54 At Week 54
Secondary Proportion of subjects with center-involved DME up to Week 54 To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to Week 54 At Week 54
Secondary Area under the curve in change 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 From Baseline in BCVA up to Week 54 and Week 96
Secondary Change from Baseline in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at Week 54 and Week 96 To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status From Baseline score to Week 54 and Week 96
Secondary Proportion of subjects with no PDR at Week 96 To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status At Week 96
Secondary Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96 To compare the effect of brolucizumab relative to PRP on ocular complications At Week 54 and Week 96
Secondary Proportion of subjects with center-involved DME up to Week 96 To compare the effect of brolucizumab relative to PRP on ocular complications At Week 96
See also
  Status Clinical Trial Phase
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Recruiting NCT01044875 - Trial of Yellow 577 nm Laser Versus Green 532 nm Laser for Proliferative Diabetic Retinopathy N/A
Active, not recruiting NCT00993525 - Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study) Phase 1/Phase 2
Completed NCT01307072 - Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy N/A
Completed NCT01758757 - Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy N/A
Withdrawn NCT00600236 - HLA and it Relation With the Development of Proliferative Diabetic Retinopathy in Mexican Population Phase 3
Completed NCT05408416 - Comparison of Surgery Outcome Between Preoperative IVR and Intraoperative IVR in PPV for PDR N/A
Completed NCT05414149 - Efficacy and Safety Comparison of IVR and IVC Before Vitrectomy in Proliferative Diabetic Retinopathy N/A
Not yet recruiting NCT04464694 - Pre-vitrectomy Intravitreal Ranibizumab for Patients With Proliferative Diabetic Retinopathy Combined With Diabetic Macular Edema Phase 4
Not yet recruiting NCT03633266 - Anti-VEGF Instead of Intraoperative PRP in Proliferative Diabetic Retinopathy N/A
Completed NCT03490318 - Effectiveness of Multimodal Imaging for the Evaluation of Retinal Oedema And New vesseLs in Diabetic Retinopathy
Completed NCT01627977 - Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy Phase 3
Completed NCT00776763 - Ocular Growth Factors Profile in Proliferative Retinopathies Before and After Intravitreal Bevacizumab Phase 2
Terminated NCT00563628 - Changes in Macular Thickness After Patterns Scan Laser Phase 4
Terminated NCT00563043 - Changes in Electroretinogram and Contrast Sensitivity After PASCAL Treatment Phase 4
Completed NCT00682240 - Morphological and Functional Retinal Changes Following Retinal Photocoagulation Phase 4
Completed NCT00446381 - Effect of Macugen(Pegaptanib)on Surgical Outcomes and VEGF Levels in Diabetic Patients With PDR (Diabetic Retinopathy or CSDME (Macular Edema) N/A
Completed NCT02879422 - Genetic Markers and Proliferative Diabetic Retinopathy N/A
Enrolling by invitation NCT02911311 - Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy N/A
Recruiting NCT05514925 - Cryoapplication Versus Anti-VEGF Before Diabetic Vitrectomy Phase 4