| CTRI Number |
CTRI/2024/08/072210 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Registry of medical retina diseases |
|
Scientific Title of Study
|
Follow up study of the patients enrolled in a hospital based multi center registry for common medical retinal diseases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IOCTN20/05 version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopal S Pillai |
| Designation |
Head of Department |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre, Kochi Kerala |
| Address |
Department Of Ophthalmology
Amrita Institute of Medical Sciences and Research Centre, Kochi Kerala
AIMS-Ponekkara P.O, Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9447391266 |
| Fax |
04842802020 |
| Email |
gopalspillai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Merin Dickson |
| Designation |
Chief Research Officer ophthalmology |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala |
| Address |
Amrita Institute if Medical Sciences and Research Centre, Kochi Kerala
AIMS-Ponekkara P.O, Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9326276469 |
| Fax |
04842802020 |
| Email |
drmerindickson@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Merin Dickson |
| Designation |
Chief Research Officer ophthalmology |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre, Kochi, Kerala |
| Address |
Amrita Institute if Medical Sciences and Research Centre, Kochi Kerala
AIMS-Ponekkara P.O, Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
9326276469 |
| Fax |
04842802020 |
| Email |
drmerindickson@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government funding agency
BIOTECHNOLOGY INDUSTRY RESEARCH ASSISTANCE COUNCIL, NEW DELHI, DELHI, 110020 India |
|
|
Primary Sponsor
|
| Name |
BIOTECHNOLOGY INDUSTRY RESEARCH ASSISTANCE COUNCIL |
| Address |
NSIC Estate, Okhla Phase III, Okhla Industrial Estate, New Delhi, Delhi 110020 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gopal S pillai |
AMRITA INSTITUTE OF MEDICAL SCIENCE KOCHI |
Department Of Ophthalmology
PONEKKARA,
EDAPILLY
Ernakulam
KERALA |
9447391266
gopalspillai@gmail.com |
| Dr Sheeba C S |
Regional Institute of Ophthalmology, Trivandrum |
Department Of Ophthalmology
Regional Institute of Ophthalmology, Trivandrum, Kerala
Thiruvananthapuram
KERALA |
9446968341
sheeba.c.s@gmai.com |
| Dr Alok Sen |
Sadguru Netra Chikitsalaya, Chithrakoot |
Department Of Ophthalmology
Sadguru Netra Chikitsalaya, Janki Kund, Chithrakoot, Madhya Pradesh
Satna
MADHYA PRADESH |
7898201605
draloksen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Amrita Institute of Medical Sciences |
Approved |
| Regional Institute of Ophthalmology |
Approved |
| Sadguru seva sangh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
observational study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with these aforementioned stages of diabetic retinopathy, 2. Central and branch retinal vein occlusions
3. Age related macular degeneration or CNVM who are already enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseasesâ€
4. Patients who were already enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseases. |
|
| ExclusionCriteria |
| Details |
Patients who were not enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the progression of the disease after the visit
|
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the real world treatment of patients who were enrolled into the registry.
2. To evaluate the efficacy of treatment of patients through change in vision.
3. To evaluate the efficacy of the treatment of patients through reduction in Central macular thickness (CMT).
4. To understand the changes |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
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)
|
20/08/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Our aim was to develop a multicentre registry in order to facilitate future RCTs in common medical retinal diseases amenable to treatment with biologics like anti VEGF. Such a registry will facilitate recruitment by matching potential participants interested in research with approved clinical studies using study entry criteria taken from patient visiting OPDs after obtaining their informed consent. The follow up study will evaluate the progression of the disease and change of visual acuity of the patients who were already enrolled in the registry entitled “A hospital-based multicentre registry for common medical retinal diseasesâ€This is a hospital based multicenter registry which will be conducted without any intervention. The data of patients who were already in the registry entitled “A hospital-based multicentre registry for common medical retinal diseases†will be collected.
Data collection includes details of any new comorbid diseases , previous diagnosis as per baseline visit, current diagnosis as per latest visit, any procedure done after baseline visit, ophthalmic assessment including best corrected visual acuity (logmar) , intraocular pressure, OCT-central macular thickness , OCT-central macular volume and mydriatic fundus photographs. The assessment of changes in continuous variable outcomes like BCVA, CMT, and CMV from baseline to follow-up involves the utilization of either Repeated Measures ANOVA or the Friedman Test. |