| CTRI Number |
CTRI/2012/08/002878 [Registered on: 13/08/2012] Trial Registered Retrospectively |
| Last Modified On: |
22/04/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a study of two modes of treatment; which are called Laser Photocoagulation alone and with drug Triamcinolone, in the patients which are suffering from eye disease caused by Diabetes Mellitus. |
|
Scientific Title of Study
|
A randomized, parallel group, open label, Comparative study of laser photocoagulation with and without intravitreal triamcinolone acetonide in clinically significant macular edema (CSME) in diabetic retinopathy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hetal J Patel |
| Designation |
second year resident |
| Affiliation |
Govt. medical college bhavnagar |
| Address |
Dhanvantri PG hostel-2 ,Room no. 504, Sir Takhatsinhji general Hospital campus, Bhavnagar-364001 ,Gujarat , India
Dhanvantri PG hostel-2 ,Room no. 504, Sir Takhatsinhji general Hospital campus, Bhavnagar-364001 ,Gujarat , India
Bhavnagar
GUJARAT
364 001
India |
| Phone |
09099987070 |
| Fax |
|
| Email |
drhetalpatel@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neepa R Gohil |
| Designation |
Assistant Professor |
| Affiliation |
Govt. medical college bhavnagar |
| Address |
Department of Ophthalmology,1 st floor, New O.P.D. Building, Sir Takhatsinhji general Hospital ,Jail road, Bhavnagar-364001 ,Gujarat , India
YASHANSHU Plot no:83-A
Vidyanagar,Chitranjan chowk
, Bhavnagar-364001 ,Gujarat , India
Bhavnagar
GUJARAT
364 001
India |
| Phone |
09909978072 |
| Fax |
|
| Email |
neepasolanki@indiatimes.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hetal J Patel |
| Designation |
second year resident |
| Affiliation |
Govt. medical college bhavnagar |
| Address |
Dhanvantri PG hostel-2 ,Room no. 504, Sir Takhatsinhji general Hospital campus, Bhavnagar-364001 ,Gujarat , India
Dhanvantri PG hostel-2 ,Room no. 504, Sir Takhatsinhji general Hospital campus, Bhavnagar-364001 ,Gujarat , India
Bhavnagar
GUJARAT
364 001
India |
| Phone |
09099987070 |
| Fax |
|
| Email |
drhetalpatel@ymail.com |
|
|
Source of Monetary or Material Support
|
| Sir Takhatsinhji general Hospital , Bhavnagar 364 001 ,Gujarat |
|
|
Primary Sponsor
|
| Name |
Govt medical college and Sir Takhatsinhji General Hospital Bhavnagar |
| Address |
Sir Takhatsinhji general Hospital ,Jail road, Bhavnagar-364001 ,Gujarat , India
|
| 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 Hetal Patel |
Department of Ophthalmology, Sir Takhatsinhji general Hospital , Bhavnagar |
Department of Ophthalmology,5 th floor, New O.P.D. building, Sir Takhatsinhji general Hospital campus,Jail road, Bhavnagar , 364 001 , Gujarat , India
Bhavnagar
GUJARAT |
9099987070
drhetalpatel@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Review Board ( Human Ethics Committee ),Govt. Medical College Bhavnagar 364 001 |
Approved |
| Institutional Review Board (Human Ethics Committee ),Govt. Medical College Bhavnagar 364 001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Diabetic Macular Edema in Diabetic Retinopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Triamcinolone Acetonide
|
Injection Triamcinolone Acetonide
4mg / 0.1ml ,single dose, Intravitreally through pars plana route
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosis of diabetes mellitus ( type or type 2).
2) Age ≥ 18 years.
3) Able and willing to provide informed consent.
4) Definite retinal thicking due to diabetic macular edema based on clinical examination involving the centre of the macula.
5) Media clarity, papillary dilatation, and patient cooperation sufficient
For adequate fundus photographs.
6) IOP < 25 mmHg
|
|
| ExclusionCriteria |
| Details |
1) History of chronic renal failure requiring dialysis or kidney transplant.
2) Known allergy to any corticosteroid or any component of the delivery vehicle.
3) History of systemic (e.g. oral, IV, IM, epidural, bursal) corticosteroids within 4 ) months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 2 times per week.
5) Proliferative diabetic retinopathy.
6) Aphakia.
7) Intraocular pressure ≥ 25 mmHg.
8) History of open angle glaucoma.
9) History of steroid-induced intraocular pressure elevation that required IOP lowering agents.
10) History of prior treatment with intravitreal corticosteroids within 6 months prior to randomization.
11) History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.
12) History of panretinal scatter photocoagulation (PRP) within prior 4 months or anticipated within the next 6 months following randomization.
13) History of major ocular surgery ( including cataract extraction, scleral buckle, any intraocular surgery etc.) within prior 6 months or anticipated within the next 6 months following randomization.
14) History of prior herpetic ocular infection.
15) An ocular condition is present such that visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, nonretinal conditions).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bestcorrecterd Visual Acuity and
Intraocular pressure |
Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any Adverse events |
Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2010 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This
study is a randomized, parallel group, open label, comparative study comparing
safety and efficacy of Laser Photocoagulation with and without intravitreal injection Triamcinolone Acetonide
in patients with clinically significant macular edema in diabetic retinopathy
that will be conducted at single centre in India. The primary outcome measures
will be best corrected visual acuity and intraocular pressure measurement. |