| 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
|
|
|
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
|
|
|
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. |