| CTRI Number |
CTRI/2024/09/073918 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Tha main outcome of study is to find the relation between factors involved in blood clotting and vascular growth factor in patients of retinal vein occlusion |
|
Scientific Title of Study
|
Relation between adenosine diphosphate stimulated platelet aggregation and vascular endothelial growth factor release in branch retinal vein occlusion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Punita Kumari Sodhi |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology, Maulana Azad Medical College and Associated Guru Nanak Eye Centre, New Delhi
Department of Ophthalmology,
Guru Nanak Eye Centre, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604414 |
| Fax |
|
| Email |
sodhipunita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Yadav |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology, Maulana Azad Medical College and Associated Guru Nanak Eye Centre, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8168396200 |
| Fax |
|
| Email |
aditi108108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditi Yadav |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Ophthalmology, Maulana Azad Medical College and Associated Guru Nanak Eye Centre, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
8168396200 |
| Fax |
|
| Email |
aditi108108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Guru Nanak Eye Centre, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and Associated Guru Nanak Eye Centre (Department of Ophthalmology), New Delhi,110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Aditi Yadav |
Maulana Azad Medical College |
Department of Ophthalmology, Guru Nanak Eye Centre
New Delhi
DELHI |
8168396200
aditi108108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H342||Other retinal artery occlusions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects having normal platelet count, prothrombin time and activated partial thromboplastin time.
2)Subjects not on any anti-platelet-aggregating drugs, anticoagulants or non-steroidal anti-inflammatory drugs.
|
|
| ExclusionCriteria |
| Details |
1)Subjects having other ocular diseases like glaucoma, media opacity, optic nerve disorders, high refractive errors, other significant co-existing retinal diseases especially those which affect macular perfusion (e.g. diabetic retinopathy, uveitis and vasculitis)
2)Subjects having best corrected visual acuity lesser than 6/60
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Platelet aggregation response to adenosine diphosphate in subjects of branch retinal vein occlusion. |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Serum levels of vascular endothelial growth factor-A (VEGF-A)
2)Posterior segment Optical Coherence Tomography parameters (Central foveal thickness and sub-foveal choroidal thickness) and Optical Coherence Tomography Angiography parameters (Foveal Avascular Zone, vessel density)
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
24/09/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
A total of thirty treatment naïve subjects in the age group of 45 to 65 years having branch retinal vein occlusion will be enrolled. A thorough history will be taken and a detailed ocular examination will be done. Platelet aggregation will be evaluated by inducing the aggregation of human platelets (250× 103/μl) with adenosine diphosphate (200 μM) using the principle of light transmission aggregometry with aggregometer (Helena AggRAM). For all the subjects, VEGF-A will be estimated by Enzyme Linked Immunosorbent Assay (ELISA) with commercially available kits |