| CTRI Number |
CTRI/2024/08/072933 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Efficacy and Safety of Fenofibrate in diabetic retinopathy |
Scientific Title of Study
Modification(s)
|
Efficacy and Safety of Fenofibrate in the Progression of 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 Ashish Thomas George |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room 4019, Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh.
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9443508709 |
| Fax |
|
| Email |
ashish240496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Kakkar |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room 4016, Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9868051003 |
| Fax |
|
| Email |
drashishkakkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Kakkar |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
Room 4016, Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9868051003 |
| Fax |
|
| Email |
drashishkakkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology. PGIMER Chandigarh - 160012
India |
|
|
Primary Sponsor
|
| Name |
Nehru Hospital PGIMER |
| Address |
Department of Pharmacology, PGIMER, Chandigarh
India 160012
160012 |
| 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 |
| Dr Ashish Thomas George |
Postgraduate Institute of Medical Education and Research, Chandigarh |
4007, 4th Floor, New OPD, Department of Endocrinology, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India
Chandigarh
CHANDIGARH |
9443508709
ashish240496@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E083||Diabetes mellitus due to underlying condition with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fenofibrate |
Participants in the intervention arm will receive fenofibrate 135 mg, taken once daily for 3 months |
| Comparator Agent |
Placebo |
Participants in the comparator arm will receive a matching placebo, taken once daily for 3 months |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged 18 years and above, of either sex, diagnosed with diabetic retinopathy.
2. Duration of diabetes mellitus for more than one year.
3. Ocular treatment–naïve patients with mild diabetic retinopathy to severe non-proliferative diabetic retinopathy, with no diabetic macular edema (DME) or non-centre-involving DME (nci-DME).
4. Patients with untreated or treated resting mean sitting systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg.
|
|
| ExclusionCriteria |
| Details |
1.Known allergy to fenofibrate.
2.Chronic kidney disease or estimated glomerular filtration rate (eGFR) less than 45 ml/min/1.73m².
3.Serum ALT greater than 3 times the ULN.
4.History of photosensitivity or myopathy/rhabdomyolysis.
5.History of pancreatitis, deep vein thrombosis, gall bladder disease, or untreated hypothyroidism.
6.Record of the occurrence or current existence of proliferative retinopathy.
7.History or presence of center-involving diabetic macular edema (ci-DME).
8.Coexisting macular diseases other than DME.
9.Historical records or documented instances of photocoagulation of the retina or intravitreal injections.
10.Patients on coumarin anticoagulant therapy.
11.Pregnant and lactating women.
12.Degree of cataract or media opacity that hinders the ability to acquire gradable retinal photographs.
13.Angle-closure glaucoma which prevents pharmacological dilation of the pupil. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Primary outcome will be advancing two or more steps for participants who had any DR at baseline in the Early Treatment Diabetic Retinopathy Study (ETDRS) severity scale, based on evaluation of stereoscopic or non-stereoscopic fundus photographs, during the follow-up period, or both (ETDRS 1991) |
At baseline and at 3 months of follow-up
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Number of patients converting from NPDR lower grade to NPDR higher grade
Number of patients converting from NPDR to PDR
Number of patients converting from no DME to DME
Number of patients converting from non centre involving DME to centre involving DME
Mean change in visual acuity
Mean change in central 1 mm OCT thickness
Mean change in vision related quality of life
Discontinuation of treatment
Adverse effects including serious adverse events |
Baseline, At the end of 3 months of followup |
|
Target Sample Size
Modification(s)
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
02/09/2024 |
| 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
Modification(s)
|
Years="2"
Months="4"
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
Modification(s)
|
This prospective, double-masked, randomized, placebo-controlled trial at PGIMER, Chandigarh will assess the efficacy and safety of oral choline fenofibrate 135 mg in patients with diabetic retinopathy over a follow-up period of 3 months. The primary outcome is progression of diabetic retinopathy, defined as advancement by two or more steps on the ETDRS severity scale. Secondary outcomes include change in OCT thickness, change in visual acuity, and safety parameters. A total sample size of 56 patients (28 per group) has been calculated to achieve 80% power at a two-sided alpha level of 0.05 |