| CTRI Number |
CTRI/2022/05/042804 [Registered on: 25/05/2022] Trial Registered Prospectively |
| Last Modified On: |
29/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find the effectivity of single injection of the drug Razumab in improving vision in the affected eye .This study will help the patients with diabetic eye problems by improving their vision and reducing the number of hospital visits. |
|
Scientific Title of Study
|
A prospective interventional study to find the effectivity of Razumab by measuring macular edema pre and post intravitreal injection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malathi VK |
| Designation |
Assistant Professor of Ophthalmology |
| Affiliation |
ESIC postgraduate institute of medical science and research |
| Address |
Department of ophthalmology, OPD block 3rd floor, OPD no.300, ESIC PGIMSR,K.K.nagar, Chennai- 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9444418536 |
| Fax |
|
| Email |
guru.ukm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Malathi VK |
| Designation |
Assistant Professor of Ophthalmology |
| Affiliation |
ESIC postgraduate institute of medical science and research |
| Address |
Department of ophthalmology, OPD block 3rd floor, OPD no.300, ESIC PGIMSR,K.K.nagar, Chennai- 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9444418536 |
| Fax |
|
| Email |
guru.ukm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Malathi VK |
| Designation |
Assistant Professor of Ophthalmology |
| Affiliation |
ESIC postgraduate institute of medical science and research |
| Address |
Department of ophthalmology, OPD block 3rd floor, OPD no.300, ESIC PGIMSR,K.K.nagar, Chennai- 600078
Chennai
TAMIL NADU
600078
India |
| Phone |
9444418536 |
| Fax |
|
| Email |
guru.ukm@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC postgraduate institute of medical science and research, K.K.nagar, Chennai-600088 |
|
|
Primary Sponsor
|
| Name |
ESIC postgraduate institute of medical science and research |
| Address |
K.K.nagar, Chennai, PIN: 600078 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Malathi VK |
ESIC postgraduate institute of medical science and research |
Department of Ophthalmology, 3rd floor, OPD block, OPD no.300, K.K.nagar, Chennai 600078
Chennai
TAMIL NADU |
09500045217
guru.ukm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, ESIC PGIMSR,K.K.nagar, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravitreal Razumab |
Razumab is an intravitreal antivascular endothelial growth factor injected intravitreally for reducing macular edema. 0.5mg of Razumab in 0.05ml will be injected intravitreally under strict aseptic precautions. The visual acuity and central macular thickness will be measured before and after 1 month of intravitreal Razumab injection. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients with diabetic macular edema or macular edema due to retinal vaso-occlussive disease with central macular thickness of less or equal to 315 micron and visual acuity of less or equal to 0.2 on LogMAR chart will be included in the study. |
|
| ExclusionCriteria |
| Details |
1. pre existing macular scar or dystrophy.
2.patients with active inflammatory and infectious diseases of the eye.
3. Patients already under treatment for macular edema in other hospital.
4.patients with history of recent ocular history or trauma.
5. patients with history of cerebrovascular or cardiovascular comorbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.the percentage of reduction of macular edema after 4 weeks.
|
1.the percentage of reduction of macular edema after 4 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in best corrected visual acuity after 4 weeks of injection of intravitreal Razumab |
1.visual acuity and macular edema will be measured before the intravitreal antivegf injection.
2. 1 week later, intraocular pressure is measured to rule out side effects.
3. 1 month after the injection, visual acuity and macular edema will be re- assessed. |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
31/05/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The visual acuity, intraocular pressure, anterior segment examination with slitlamp,microscope is done. Retinal examination is done with indirect ophthalmoscopy after dilating the pupils with Tropicamide 0.8% and phenylephrine 5%. Optical coherence tomography (OCT) is done to measure the macular edema. antivascular endothelial growth factor biosimilar Razumab 0.5mg in 0.05ml is given intravitreally under strict aseptic precuations. Patients are followed up after 1 week and then after 4 weeks.The best corrected visual acuity is recorded with LogMAR chart and the macular thickness measured with OCT. 2 tailed paired T test will be used to find the difference between pre and post single dose of intravitreal Razumab. |