| CTRI Number |
CTRI/2021/11/038069 [Registered on: 16/11/2021] Trial Registered Prospectively |
| Last Modified On: |
11/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of nepafenac 0.1% and 0.3% eye drops in management of DME |
|
Scientific Title of Study
|
Comparison of 0.1% Nepafenac and 0.3% Nepafenac eye drops in reduction of macular thickness and improvement of visaul acuity in patient with diabetic macular edema - a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MRUGANK PATEL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE AND MEDICAL EDUCATION AND RESEARCH |
| Address |
MRUGANK D PATEL , OLD HOSPITAL BLOCK, JIPMER CAMPUS DHANVANTRI NAGAR, PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9426894881 |
| Fax |
|
| Email |
mrugankpatel10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit kumar Deb |
| Designation |
Assistant professor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE AND MEDICAL EDUCATION AND RESEARCH |
| Address |
OLD HOSPITAL BLOCK, NEAR AMRIT PHARMACY, OPP TO SSB, JIPMER CAMPUS, DHANVANTRI NAGAR, PONDICHERRY - 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843126534 |
| Fax |
|
| Email |
amitjipmer@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit kumar Deb |
| Designation |
Assistant professor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POSTGRADUATE AND MEDICAL EDUCATION AND RESEARCH |
| Address |
Department of ophthalmology, OLD HOSPITAL BLOCK, NEAR AMRIT PHARMACY, OPP TO SSB, JIPMER CAMPUS, DHANVANTRI NAGAR, PONDICHERRY - 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9843126534 |
| Fax |
|
| Email |
amitjipmer@yahoo.co.in |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
JIPMER PONDICHERRY |
| Address |
JIPMER, JIPMER CAMPUS, DHANVANTRI NAGAR, PONDICHERRY, 605006 |
| Type of Sponsor |
Government medical college |
|
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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 |
| MRUGANK PATEL |
Department of ophthalmology JIPMER HOSPITAL |
Department of ophthalmology JIPMER, JIPMER CAMPUS, DHANVANTRI NAGAR, PONDICHERRY, 605006
Pondicherry
PONDICHERRY |
9426894881
mrugankpatel10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H30-H36||Disorders of choroid and retina, (2) ICD-10 Condition: H358||Other specified retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NEPAFENAC 0.1% EYE DROPS |
Nepafenac (Alcon Research, Ltd., Fort Worth, TX), is a topical NSAID which rapidly permeates through the cornea and gains intra-ocular entry. It is then converted to its active metabolite, amfenac, primarily in the retina-choroid and the iris-ciliary body. Amfenac is a potent inhibitor of constitutive (cyclooxygenase-1) and inducible (cyclooxygenase-2) cyclooxygenases that catalyze the formation of proinflammatory prostaglandins. Nepafenac 0.1 % eye drops to be instill three times a day for 6 months |
| Intervention |
NEPAFENAC 0.3 % EYE DROPS |
Nepafenac (Alcon Research, Ltd., Fort Worth, TX), is a topical NSAID which rapidly permeates through the cornea and gains intra-ocular entry. It is then converted to its active metabolite, amfenac, primarily in the retina-choroid and the iris-ciliary body. Amfenac is a potent inhibitor of constitutive (cyclooxygenase-1) and inducible (cyclooxygenase-2) cyclooxygenases that catalyze the formation of proinflammatory prostaglandins. Nepafenac 0.3 % eye drops to instill once a day for 6 months |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age > 18 years
2. DME- macular thickness > 250 microns
3. BCVA – 6/12 or better, 20/40 letters of ETDRS chart.
|
|
| ExclusionCriteria |
| Details |
1. Any ocular surgical procedure in past 3 months
2. Any laser/ intra-vitreal injection procedures in past 3 months.
3. Any patient who had undergone cataract surgery in the study eye in past 1 year.
4. Vision 6/18 or poor or 20/60 on ETDRS chart.
5. Uncontrolled sugar
6. Any previous history of allergy to nepafenac.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction of Central sub-field (CSF) macu-lar thickness.
2. No. of eyes with at least 5 letters decrease or increase from baseline in ETDRS chart.
|
1st, 4th, 6th months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Change in OCT central sub-foveal choroidal thickness from baseline. |
1st, 4th, 6th months |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2021 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
IN THIS STUDY WE WILL COMPARE NEPAFENAC 0.1% EYE DROPS AND NEPAFENAC 0.3% EYE DROPS IN PATIENTS WITH DIABETIC MACULAR EDEMA. PATIENTS MEETING THE INCLUSION CRITERIA WILL BE RECRUITED IN THE STUDY WITH CONSENT AND WILL BE RANDOMIZED IN TO 2 GROUP. GROUP 1 WILL RECEIVE NEPAFENAC 0.1 % EYE DROPS, TO BE INSTILLED IN TO AFFECTED EYE THREE TIMES A DAYS FOR SIX MONTHS. GROUP 2 WILL RECEIVE NEPAFENAC 0.3% EYE DROPS, TO BE INSTILLED IN TO AFFECTED EYE ONCE DAILY FOR SIX MONTHS. BASELINE MACULAR THICKNESS WILL BE COMPARED FOR ALL THE PATIENT ON RECRUITMENT OF THE PATIENT IN THE SUTDY AND PATIENT WILL BE FOLLOWED FOR 6 MONTHS ON 1ST, 4TH AND SIXTH MONTH VISIT. IN ALL THE VISITS MACULAR THICKENESS WILL BE RECORED AND WILL BE COMPARED WITH BASE LINE MACULAR THICKENESS. FINALLY TWO GROUPS WILL COMPARED IN TERMS OF REDUCTION OF MACULAR THICKENESS. MACULAR THICKNESS WILL BE RECORDED BY INVESTIGATION KNOW AS OPTICAL COHERENCE TOMOGRAPHY. BASELINE VISUAL ACUTIY WILL ASLO BE RECORDED USING EDTRS CHART AND WILL BE COMPARED IN SUBSEQUENT VISITS.
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