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CTRI Number  CTRI/2020/09/028038 [Registered on: 24/09/2020] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study of efficacy and safety of brolucizumab versus panretinal photocoagulation laser in patients with proliferative diabetic retinopathy 
Scientific Title of Study   A 96-week, two-arm, randomized, single-masked, multi-center, phase III study assessing the efficacy and safety of brolucizumab 6mg compared to panretinal photocoagulation laser in patiemts with proliferative diabetic retinopathy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CRTH258D2301 Version 00 dated 25-Nov-2019  Protocol Number 
NCT04278417  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Scientific Query  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Details of Contact Person
Public Query  
Name  Murugananthan K 
Designation  Country Monitoring Head 
Affiliation  Novartis Healthcare Private Limited 
Address  Novartis Healthcare Private Limited 6 and 7 floor Inspire BKC G Block BKC Main Road Bandra Kurla Complex Bandra (East) Mumbai

Mumbai
MAHARASHTRA
400051
India 
Phone  912250243544  
Fax    
Email  murugananthan.k@novartis.com  
 
Source of Monetary or Material Support  
Novartis Pharma AG, Novartis Campus 4056 – Basel, Switzerland 
 
Primary Sponsor  
Name  Novartis Healthcare Pvt Ltd 
Address  6 & 7 floor, Inspire BKC, G Block, BKC Main Road, Bandra Kurla Complex, Bandra (East), Mumbai – 400051,India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Australia
Brazil
Canada
Chile
China
India
Japan
Mexico
Philippines
Republic of Korea
Russian Federation
Saudi Arabia
Taiwan
Turkey
United States of America  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajpal Vohra  All India Institute Of Medical Sciences  Dr.R.P Center of Opthalmic Science, All India Institute Of Medical Sciences, Sri Aurobindo Marg, Ansari Nagar, New Delhi-110029, India
New Delhi
DELHI 		 9818598899

vohrarajpal@gmail.com 
Dr Veerappan Rathinasabapathy Saravanan  Aravind Eye Hospital  Avinashi Rd, Civil Aerodrome Post, Sitra, Coimbatore, Tamil Nadu 641014
Coimbatore
TAMIL NADU 		 9244401310

saravananvr@gmail.com 
Dr D Lional Raj  Dr. Agarwals Eye Hospital  No 10, South bypass Road, Vannarpettai, Tirunelveli-627002
Tirunelveli
TAMIL NADU 		 8754411261

drlionalraj@dragarwal.com 
Dr Gonsai Jigneshgiri Yashvantgiri  Government Eye Hospital, M & J Institute of Ophthalmology  Director Office, Manjushri Mill Compound, Asarwa, Ahmedabad- 380016, Gujarat
Ahmadabad
GUJARAT 		 9824321195

dr_jigneshgosai@hotmail.com 
Dr Vishali Gupta  Post Graduate Insitute of Medical Edication and Research  Advance Eye Centre, Sector 12, Chandigarh-160012
Chandigarh
CHANDIGARH 		 9417565506

vishalisara@gmail.com 
Dr Ashish Kakkar  Shri Mahant Indiresh Hospital  Patel Nagar, Dehradun, Uttarakhand 248001
Dehradun
UTTARANCHAL 		 9289790084

ashishkakkar2007@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Dr Agarwals Eye Hospital Institutional Review Board, Dr. Lional Raj  Approved 
Institute Ethics Committee, All India Institute Of Medical Sciences, Dr Rajpal Vohra  Approved 
Institutional Ethics Committee, Shri Guru Ram Rai lnstitute of Medical & Health Sciences Shri Mahant Indiresh Hospital, Dr Ashish Kakkar  Approved 
Institutional Ethics Committee; Institutional Ethics Committee, B.J Medical College and Civil Hospital, Dr.Jignesh Gosai  Approved 
Institutional Ethics Committee; Post Graduate Insitute of Medical Education and Research, Dr. Vishali Gupta  Approved 
Institutional Human Ethics Committee; PSG Institute of Medical Sciences & Research, Dr. Veerappan Saravanan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H538||Other visual disturbances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Brolucizumab 6 mg (RTH258 6 mg/ 0.05 mL) 3 X q6w loading then q12w maintenance through Week (), with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time upto 24 weeks  Solution for injection; Intravitreal 
Comparator Agent  Panretinal Photocoagulation Laser Initial treatment in 1-2 sessions upto week 12, followed with additional PRP treatment as needed upto Week 90.  PRP is a procedure which is Standard of Care in proliferative diabetic retinopathy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Signed informed consent must be obtained prior to participation in the study.

2. Patients olde than or equal to 18 years of age at screening.

3. Participant cooperation sufficient for adequate fundus photographs and retinal images.

4. Patients diagnosed with type 1 or 2 DM and HbA1c more than or equal to 12 percent at screening.

5. 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.

6. 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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="706"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/12/2020 
Date of Study Completion (India) 24/07/2024 
Date of First Enrollment (Global)  01/05/2020 
Date of Study Completion (Global) 19/08/2024 
Estimated Duration of Trial   Years="3"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   To evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR) 
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