| CTRI Number |
CTRI/2025/09/094432 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two strengths of Nepafenac eyedrops (0.3 and 0.1 percent) to prevent inflammation after pan retinal photocoagulation in diabetic retinopathy |
|
Scientific Title of Study
|
Comparative efficacy of Nepafenac 0.3 percent once daily versus Nepafenac 0.1 percent thrice daily eyedrops in preventing macular edema following pan retinal photocoagulation in diabetic retinopathy. |
| 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 Supriya Pandharinath Dhondge |
| Designation |
Secondary DNB Resident in Ophthalmology |
| Affiliation |
Sankara Eye Hospital ,Guntur ,Andhra Pradesh |
| Address |
OPD no 107,Retina department Sankara Eye Hospital, Guntur-Vijayawada express highway. Pedakakani , 522509, Guntur, Andhra Pradesh,India.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
08888726268 |
| Fax |
|
| Email |
supriyapd333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayamadhury Gudimetla |
| Designation |
Senior Retina Consultant |
| Affiliation |
Sankara Eye Hospital ,Guntur ,Andhra Pradesh |
| Address |
OPD no 107, Retina department,Sankara Eye Hospital, Guntur-Vijayawada express highway. Pedakakani , 522509, Guntur, Andhra Pradesh,India.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
09885335077 |
| Fax |
|
| Email |
drjayamadhury@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Pandharinath Dhondge |
| Designation |
Secondary DNB Resident in Ophthalmology |
| Affiliation |
Sankara Eye Hospital ,Guntur ,Andhra Pradesh |
| Address |
OPD no 107, Retina department Sankara Eye Hospital, Guntur-Vijayawada express highway. Pedakakani , 522509, Guntur, Andhra Pradesh,India.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
08888726268 |
| Fax |
|
| Email |
supriyapd333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Guntur-Vijayawada express highway, Pedakakani , 522509, Guntur, Andhra Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Dr Supriya Pandharinath Dhondge |
| Address |
OPD no 107 ,Sankara Eye Hospital, Guntur-Vijayawada express highway, Pedakakani , 522509, Guntur, Andhra Pradesh. |
| Type of Sponsor |
Other [self ] |
|
|
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 Supriya Pandharinath Dhondge |
Sankara Eye Hospital ,Guntur ,Andhra Pradesh |
OPD no 107 ,Sankara Eye Hospital, Guntur-Vijayawada express highway. Pedakakani , 522509, Guntur, Andhra Pradesh.
Guntur
ANDHRA PRADESH |
08888726268
supriyapd333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee-Sankara Eye Hospital-Guntur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H358||Other specified retinal disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nepafenac 0.1% eyedrop (Nepalact) |
Dose:0.1%
Frequency:3 times per day (at 8am-2pm-8pm by attendant)
Route: Topical
Duration: 6 weeks |
| Comparator Agent |
Nepafenac 0.3% eyedrop (Nepalact -Z) |
Dose:0.3%
frequency:1 time per day (at 8 am by attendant)
Route:Topical
Duration: 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All cases undergoing Pan retinal photocoagulation with proliferative Diabetic Retinopathy
2.Central Macular Thickness less than 300 microns |
|
| ExclusionCriteria |
| Details |
1.Dry eye
2.Prior history of intravitreal injections or focal laser less than 6 months ago
3.Presence of incomplete Pan retinal photocoagulation
4.Any vitreo-retinal interface pathology like epiretinal membrane or vitreo-macular traction
5.Patients who lost follow up
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| visual Acquity (by LogMAR chart) |
after PRP1, after PRP2, after PRP3 and 1 month, 2 months and 3 months after PRP3.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Central Macular Thickness (Documented by OCT) |
after PRP1, after PRP2, after PRP3 and 1 month, 2 months and 3 months after PRP3.
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
To compare the efficacy of Nepafenac 0.3 percent once daily versus Nepafenac 0.1 percent three times a day in preventing an increase in central macular thickness following Pan Retinal Photocoagulation in Diabetic Retinopathy To Assess changes in best corrected visual acuity by LogMAR and evaluate the changes in Central Macular Thickness by OCT after PRP1, after PRP2, after PRP3 and 1 month, 2 months and 3 months after PRP3.
|