| CTRI Number |
CTRI/2015/10/006250 [Registered on: 12/10/2015] Trial Registered Retrospectively |
| Last Modified On: |
10/10/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
retrospective interventional study |
| Study Design |
Other |
|
Public Title of Study
|
complications of injection given in the eye for retinal diseases |
|
Scientific Title of Study
|
to study complications of intraviteral injection of bevacizumab |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sonia gupta |
| Designation |
fellow retina |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9827077038 |
| Fax |
|
| Email |
soniagupta17@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
sonia gupta |
| Designation |
fellow retina |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9827077038 |
| Fax |
|
| Email |
soniagupta17@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
sonia gupta |
| Designation |
fellow retina |
| Affiliation |
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL |
| Address |
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
256/14, kanakapura main road, 7th block, jayanagar, bangalore. 560082
KARNATAKA
560082
India |
| Phone |
9827077038 |
| Fax |
|
| Email |
soniagupta17@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL |
|
|
Primary Sponsor
|
| Name |
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL |
| Address |
NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL, 256/14, kanakapura main road, 7th block, jayanagar, bangalore |
| 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 |
| Sonia Gupta |
Retina department,nethradhama superspeciality eye hospital |
Nethradhama superspeciality eye hospital, 256/14, kanakapura main road, 7th block, jayanagar, bangalore
Bangalore
KARNATAKA |
9827077038
soniagupta17@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NETHRADHAMA SUPERSPECIALITY EYE HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
healthy patients who had given intravitreal bevacizumab for ocular problem
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Age > 18 years
•Any evidence of ocular neovascularisation, Choroidal neovasular membrane, macular edema due to retinal vein occlusion, diabetic retinopathy
|
|
| ExclusionCriteria |
| Details |
•Active external eye infection like conjunctivitis, meibomitis etc.
•Ischemic maculopathy
•Presence of any active systemic infections |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study ocular complications within a year of intravitreal injection of bevacizumab.
|
day1 and at 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
yet to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After considering for inclusion and exclusion criteria patients which were given intravitreal bevacizumab were recorded including their best corrected visual acuity, disease for which intravitreal injection was given number of injections given, slit lamp examination and fundus findings. complications if any were recorded with its duration and management given for the same was also noted down. |