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CTRI Number  CTRI/2020/10/028459 [Registered on: 19/10/2020] Trial Registered Prospectively
Last Modified On: 11/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Hydroxychloroquine retinopathy in patients with Rheumatic Diseases. 
Scientific Title of Study   The Incidence of Retinopathy in Rheumatic and Musculoskeletal Disease patients on long term Hydroxychloroquine (HCQ) use - A Prospective Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
YH-AR-S2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arindam Nandy Roy 
Designation  Consultant Rheumatologist 
Affiliation  Yashoda Hospitals 
Address  Cabin No 184,1st Floor Behind Hari Hara Kala Bhavan
S D Road
Hyderabad
TELANGANA
500003
India 
Phone  9849279830  
Fax    
Email  doctor.arindam@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arindam Nandy Roy 
Designation  Consultant Rheumatologist 
Affiliation  Yashoda Hospitals 
Address  Cabin No 184,1st Floor Behind Hari Hara Kala Bhavan
S D Road
Hyderabad
TELANGANA
500003
India 
Phone  9849279830  
Fax    
Email  doctor.arindam@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arindam Nandy Roy 
Designation  Consultant Rheumatologist 
Affiliation  Yashoda Hospitals 
Address  Cabin No 184,1st Floor Behind Hari Hara Kala Bhavan
S D Road
Hyderabad
TELANGANA
500003
India 
Phone  9849279830  
Fax    
Email  doctor.arindam@yahoo.com  
 
Source of Monetary or Material Support  
Yashoda Hospitals Secunderabad 
 
Primary Sponsor  
Name  Dr Arindam Nandy Roy 
Address  Cabin No 184,1st Floor Yashoda Hospitals Behind Hari Hara Kala Bhavan S D Road Secunderabad-500003 Telangana,INDIA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arindam Nandy ROy  Yashoda Hospitals  Room No 184,1st Floor Department of Rheumatology Behind Hari Hara Kala Bhavan,S.D.Road Secunderabad-500003
Hyderabad
TELANGANA 
9849279830

doctor.arindam@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - YAMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M138||Other specified arthritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  HYDROXYCHLOROQUINE  200 mg per day Route of Administration - Oral Duration : At least 05 years 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Able to provide signed consent form.
Subjects clinically diagnosed to have rheumatic and musculoskeletal diseases.
Subjects willing to take HCQ for long duration
 
 
ExclusionCriteria 
Details  1. Preexisting ocular conditions of the anterior segment or the retina causing defective vision.
2. Are taking a medication other than HCQ with retinotoxic side effects (Tamoxifen).
3. Known hypersensitivity to 4-aminoquinoline compounds (such as Chloroquine or hydroxychloroquine).
4. Previous exposure to HCQ.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To identify the incidence and risk factors of retinopathy in patients of rheumatic and musculoskeletal diseases using long term HCQ by modern screening methods.  After 01 year( later each year ) 
 
Secondary Outcome  
Outcome  TimePoints 
Skin hyper pigmentation  after 06 months 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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   N/A 
Date of First Enrollment (India)   19/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Hydroxychloroquine (HCQ) is an anti-malarial drug with immune-modulatory properties. It has also shown benefits in treating rheumatic and musculoskeletal diseases such as systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and scleroderma . The risk of developing irreversible retinopathy and consequent vision loss is a possible serious complication with HCQ use . Modern screening can detect retinopathy early so that necessary dose modification/stoppage of the drug will stop progression of the same.

HCQ retinopathy is defined as the presence of a single consistent abnormal test result (in case of HVF-repeated results) with normal findings in others (Possible retinopathy) or presence of definite abnormalities in two tests (one subjective and one objective-Definite retinopathy).

In recent times, there is no prospective study to identify the incidence of this retinopathy though retrospective studies are available. The prevalence of retinopathy in long term use patients appears to be around 7.5% at 5 years .

Baseline Examination:

All the demographic factors such as age, gender, height, weight, BMI, history of diabetes, hypertension and other systemic diseases and medications will be taken. Preliminary Vision testing & refraction, intraocular pressure recording, slit lamp biomicroscopy will be done to rule out any anterior segment anomalies followed by 90D fundus examination. Retinopathy secondary to diabetes, hypertension,  age related macular degeneration, glaucoma and other retinopathies will be excluded by fundoscopy. OCT, field analysis and other investigations will be done wherever necessary by the ophthalmologist.

Annual Screening:

Annual screening examinations will include automated HVF (24-2) and SD-OCT with optional fundus autofluorescence (FAF) and/or multifocal electroretinogram (mfERG) as needed.

 
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