| CTRI Number |
CTRI/2025/08/093218 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intravitreal Ranibizumab plus PRP vs PRP only] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to compare efficacy of intravitreal injection (ranibizumab) plus laser vs only laser in proliferative diabetic retinopathy |
|
Scientific Title of Study
|
Panretinal photocoagulation vs panretinal
photocoagulation with single injection of intravitreal anti-vascular endothelial growth factor
for the treatment of proliferative diabetic retinopathy: a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JIP/IECIS-4/0525/49 Version 2.0 16.06.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHREYAS S TEMKAR |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Ophthalmology, 1st floor, Hospital block, JIPMER, Puducherry - 605006
JIPMER campus, Dhanvantari Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
09353370342 |
| Fax |
|
| Email |
shreyastemkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHREYAS S TEMKAR |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Ophthalmology, 1st floor, Hospital block, JIPMER, Puducherry - 605006
JIPMER campus, Dhanvantari Nagar
PONDICHERRY
605006
India |
| Phone |
09353370342 |
| Fax |
|
| Email |
shreyastemkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHREYAS S TEMKAR |
| Designation |
Assistant Professor |
| Affiliation |
JIPMER |
| Address |
Department of Ophthalmology, 1st floor, Hospital block, JIPMER, Puducherry - 605006
JIPMER campus, Dhanvantari Nagar
PONDICHERRY
605006
India |
| Phone |
09353370342 |
| Fax |
|
| Email |
shreyastemkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantarinagar, Pondicherry - 605006 |
|
|
Primary Sponsor
|
| Name |
Dr Astha Kansal |
| Address |
DR. Astha Kansal, Junior resident, Department of Ophthalmology, Hospital block, JIPMER, Pondicherry, India 605006 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shreyas Temkar S |
Dr. Shreyas Temkar S, Assistant Professor, Department of Ophthalmology, Hospital block, JIPMER, Pondicherry |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Astha Kansal |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Department of Ophthalmology, Number 71, 1st floor, Hospital block
Pondicherry
PONDICHERRY |
6398149394
asthakansal03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Interventional Studies JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H350||Background retinopathy and retinalvascular changes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravitreal Ranibizumab |
Single injection of intravitreal Ranibizumab (0.5mg/0.05ml)followed by Panretinal photocoagulation (PRP)after 1 week.
Total 3 weekly sittings of PRP will be given . |
| Comparator Agent |
Panretinal Photocoagulation |
Panretinal Photocoagulation-3 weekly sittings. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with diabetes (type 1 or type 2)
2. Age more than or equal to 18 years
3. Proliferative diabetic retinopathy which the treating physician intends to manage with PRP .
4. Media clarity, pupillary dilation, and individual cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT |
|
| ExclusionCriteria |
| Details |
Ocular exclusion criteria
1. History of prior PRP
2. Centre involving diabetic macular edema (central subfield thickness of more than or equal to 290µm in women, 305µm in men) (OCT shall be done on Zeiss Cirrus 500)
3. History of receiving intravitreal anti-VEGF or steroid injections in the previous 4 months
4. Macular tractional retinal detachment
5. Presence of vitreous haemorrhage dense enough to preclude successful completion of PRP (as per decision of treating physician)
6. History of prior vitrectomy surgery
Systemic exclusion criteria
1. Poor diabetes control (HbA1C more than 12 percent)
2. Poor systemic condition (end stage renal disease on dialysis or other diseases which the treating physician feels can have a significant contribution to the progression of diabetic retinopathy)
3. Inability to follow up at regular intervals
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patterns of regression of retinal neovascularization
2. Completeness of PRP and the need for additional laser
3. Central subfield thickness
4. Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranes |
6 weeks, 3 months, 6 months post last PRP session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Completeness of PRP and the need for additional laser |
6 weeks, 3 months, 6 months post last PRP session |
| Central subfield thickness |
6 weeks, 3 months, 6 months post last PRP session |
| Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranes |
6 weeks, 3 months, 6 months post last PRP session |
| Visual acuity differences |
6 weeks, 3 months, 6 months post last PRP session |
| Need for PPV |
6 weeks, 3 months, 6 months post last PRP session |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
01/09/2025 |
| 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="2"
Months="0"
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
|
This study is a randomized controlled trial, comparing the efficacy of a single intravitreal anti-VEGF injection (ranibizumab) plus panretinal photocoagulation against panretinal photocoagulation monotherapy. The primary objective is to compare the regression patterns of retinal neovascularization between
panretinal photocoagulation alone and anti-VEGF with panretinal
photocoagulation in patients with proliferative diabetic retinopathy. The secondary objectives are to
compare - the visual acuity differences, differences in central subfiled thickness, the
incidence rates of vitreous hemorrhage, epiretinal membrane, and tractional retinal detachment, and the
need for pars plana vitrectomy. These objectives will be assessed at 6 weeks, 3 months and 6 months after last sitting of retinal photocoagulation. The study will help us to answer if adding a single injection of ranibizumab helps in decreasing the risk of progression to advanced proliferative diabetic retinopathy. |