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CTRI Number  CTRI/2024/02/062287 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 05/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To evaluate the safety of study drug administered in patients with Uveitic Macular Edema (Eye Disease) 
Scientific Title of Study   A Phase III, Multicenter, Randomized, Double‑Masked, Sham‑Controlled Study To Investigate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of RO7200220 Administered Intravitreally In Patients With Uveitic Macular Edema 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GR44278_Protocol Version 1.0 dated 30 Aug 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Viraj Suvarna 
Designation  Medical Chapter Lead and Chief Medical Officer (ad interim) 
Affiliation  Roche Products (India) Pvt. Ltd. 
Address  Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086

Mumbai
MAHARASHTRA
400086
India 
Phone  022-50457300  
Fax    
Email  viraj.suvarna@roche.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Manjula Ujagiri 
Designation  Manager -Clinical Operations 
Affiliation  Roche Products (India) Pvt. Ltd. 
Address  Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg, Ghatkopar, Mumbai - 400 086

Mumbai
MAHARASHTRA
400086
India 
Phone  9819154456  
Fax    
Email  manjula.ujagiri@roche.com  
 
Source of Monetary or Material Support  
Roche Products India Pvt Ltd  
 
Primary Sponsor  
Name  F HoffmannLa Roche Ltd  
Address  Grenzacherstrasse 124, CH-4070 Basel, Switzerland  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Roche Products India Pvt Ltd   146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall,Lal Bahadur Shastri Marg,Ghatkopar,Mumbai 
 
Countries of Recruitment     Argentina
Australia
Czech Republic
France
Germany
India
Japan
Singapore
Spain
Switzerland
Turkey
United States of America  
Sites of Study  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S R Rathinam  Aravind Eye Hospital   Uveitis Services, 1,,Anna Nagar, Madurai - 625020, Tamil Nadu, India
Madurai
TAMIL NADU 		 8015911306

rathinam@aravind.org 
Dr Shahana Mazumdar  ICARE Eye Hospital & PG Institute  Retina Department, ICARE Mohni Sbharwal Wing; No 10-18 and Research Wing, E3A, Sector-26, Gautam Buddha Nagar, Noida - 201301, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 9818575883

shahana.mazumdar@gmail.com 
Dr Mudit Tyagi  L V Prasad Eye Institute  Kallam Anji Reddy Campus, L.V. Prasad Marg, Banjara Hills, Hyderabad, Telangana, India, 500034
Hyderabad
TELANGANA 		 9553339042

drmudit@lvpei.org 
Dr Ankush Kawali  Narayana Nethralaya Hospital  121/C, 1st R Block, ,Chord Road, Rajajinagar- 560 010 Bangalore, Karnataka, India
Bangalore
KARNATAKA 		 9632368641

akawali332@gmail.com 
Dr Vikas Kanauji  Sanjay Gandhi Postgraduate Institute of Medical Sciences  SaRaebareli Road, Lucknow, Uttar Pradesh 226014, India
Lucknow
UTTAR PRADESH 		 9984241473

kanaujiavikas2011@gmail.com 
Dr Jyotirmay Biswas  Sankara Nethralaya  Dept. of Ocular Pathology, New No. 41, Vision Research Foundation,18 College Road, Chennai - 600 006, Tamil Nadu, India
Chennai
TAMIL NADU 		 9600019098

drjb@snmail.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
ICARE EYE HOSPITAL AND PGI ETHICS COMMITTEE  Approved 
Instituitional Ethics Committee - PGIMER, Chandigarh  Approved 
Institutional Ethics Committee Aravind Eye Hospital  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE Sanjay Gandhi Postgraduate Institute  Not Applicable 
Institutional Review Board - Ethics Committee Vision Research Foundation  Approved 
L V Prasad Eye Institute Ethics Committee  Approved 
NARAYANA NETHRALAYA ETHICS COMMITTEE  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H579||Unspecified disorder of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  IL-6 Monoclonal Antibody-RO7200220  IL-6 Monoclonal Antibody Solution for IVT Injection 20 mg/mL and 5 mg/mL, depending on the dose Dosage level - Arm A: 1 mg, Arm B: 0.25 mg No dose in Arm C packaging - 2‑mL glass vials Arms A and B will receive RO7200220 Q4W from Day 1 through Week 12, followed by RO7200220 PRN dosing from Week 20 through Week 48. 
Comparator Agent  Sham Treatment (Placebo)  The sham vial is empty and will remain empty throughout the sham treatment. The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Participants randomized to Arm C will receive sham injections Q4W from Day 1 to Week 12. To preserve masking for the duration of the study, participants in Arm C will also undergo PRN sham dosing regimen starting at Week 20 to Week 48. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Diagnosis of non infectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis)
2. Active and inactive NIU is allowed.
3. Macular edema due to NIU defined as CST more than equal to 325 um on Spectralis SD-OCT or more than equal 315 um on Topcon or Cirrus at screening evaluated by CRC
4. BCVA letter score of 73 to 19 letters (both inclusive) on ETDRS-like charts (20 OR 40 to 20 OR 400 Snellen equivalent) at Day 1
 
 
ExclusionCriteria 
Details  1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study
2. Evidence of active or latent syphilis infection
3. Evidence of active or latent tuberculosis infection, or previous or current HIV diagnosis
4. Serious acute or chronic medical illness
5. Blood transfusion within 12 months prior to screening
6. Any major non‑ocular surgical procedure within 1 month prior to Day 1
7.Any febrile illness within 1 week prior to Day 1
8. Any known hypersensitivity to fluorescein, dilating eye drops, or topical anesthetic eye drops 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proportion of participants with 15 letter improvement from baseline in BCVA at Week 16  From baseline to Week 16 
 
Secondary Outcome  
Outcome  TimePoints 
1. Proportion of participants with 15 letter improvement from baseline in BCVA at Week 20 (8 weeks after the final study drug dose)
2.Change from baseline in CST (central subfield thickness)at Week 16.
 		 1. From Baseline to week 20
2. From Baseline to week 16 
Other Secondary Outcomes
1.Change from baseline in BCVA and CST at Weeks 20 and 52
Number and type of rescue treatments received and time taken.
2. Number of PRN injections received and time to 1st PRN injection
3. Change from baseline in the NEI VFQ‑25 composite score at Weeks 16 and 52
4.Incidence and severity of adverse events and AESIs
5.Percent change from baseline in corneal endothelial cell (CEC) density at Week 24 & 52
 		 Week 16, Week 24 and Week 52 (as applicable) 
PK/ PD Outcome
1. AH concentration
2. Serum concentration,
3. IL‑6 suppression in AH 		 During the study conduct, as applicable 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/12/2022 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not available 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of RO7200220, a novel recombinant, humanized anti interleukin 6 (IL 6) monoclonal antibody. RO7200220 is administered by intravitreal (IVT) injection in patients with uveitic macular edema, a sight threatening complication of non infectious uveitis (NIU) (hereafter referred to as uveitic macular edema secondary to NIU and will be referred to as “UME”). Systemic or local (IVT or periocular) corticosteroid therapies are the most common treatments for UME but are associated with significant adverse effects. There is an unmet need for effective non steroidal therapies for UME that do not have corticosteroid related adverse effects and that have an improved or positive benefit risk balance for treatment of patients with UME. 
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