| CTRI Number |
CTRI/2025/07/090990 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of response following dexamethasone implant followed by anti VEGF injections with ranibizumab and aflibercept monotherapy |
|
Scientific Title of Study
|
The OZPRIME study- Assessing efficacy and response variance after dexamethasone implant priming with two different types of AntiVEGF agents- A randomized control trial. |
| 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 Unnikrishnan Nair |
| Designation |
Senior Consultant and Medical Director |
| Affiliation |
Chaithanya Eye Hospital and research institute |
| Address |
Chaithanya Eye Hospital, Kesavadasapuram,
Thiruvananthapuram,
Kerala
Department of Vitreoretinal services, Chaithanya Eye Hospital and research institute, Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
9947272020 |
| Fax |
|
| Email |
dr.unninair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shinu Muralidharan T |
| Designation |
Consultant |
| Affiliation |
Chaithanya Eye Hospital and research institute |
| Address |
Chaithanya Eye Hospital, Kesavadasapuram,
Thiruvananthapuram,
Kerala
Department of Vitreoretinal services, Chaithanya Eye Hospital and research institute, Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
9447392873 |
| Fax |
|
| Email |
shinumurali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shinu Muralidharan T |
| Designation |
Consultant |
| Affiliation |
Chaithanya Eye Hospital and research institute |
| Address |
Chaithanya Eye Hospital, Kesavadasapuram,
Thiruvananthapuram,
Kerala
Department of vitreoretinal services, Chaithanya Eye Hospital and research institute,
Kesavadasapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
9447392873 |
| Fax |
|
| Email |
shinumurali@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaithanya Eye Hospital and research institute, Kesavadasapuram, Thiruvananthapuram, Pin 695004 |
|
|
Primary Sponsor
|
| Name |
Chaithanya Eye Hospital and research institute |
| Address |
Chaithanya Eye Hospital and research institute, Kesavadasapuram, Thiruvananthapuram, Pin 695004
|
| 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 Shinu Muralidharan Tekkedil |
Chaithanya Eye Hospital and Research Institute |
Department of vitreoretinal services
Thiruvananthapuram
KERALA |
9447392873
shinumurali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CEHRI-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inrtavitreal Ranibizumab 0.5 mg injection |
In Ranibizumab monotherapy group, intra vitreal Anti VEGF injection Ranibizumab 0.5 mg will be given monthly for 4 months. At 5th month, Ranibizumab 0.5 mg intravitreal injection will be given unless stability criteria is achieved. |
| Comparator Agent |
Intravitreal Aflibercept 2 mg injection |
In Aflibercept monotherapy group, Aflibercept intravitreal injection 2 mg will be given monthly for 4 months. At 5th month, Aflibercept intravitreal injection 2 mg will be given unless stability criteria is achieved. |
| Intervention |
Intravitreal Dexamethasone implant 0.7 mg injection at baseline visit followed by intravitreal Ranibizumab o.5 mg injection at 4 th and 5 th month from baseline visit |
At the baseline study visit, enrolled patients will be randomized in a 1:1:1 ratio into three groups – OZPRIME group, ranibizumab monotherapy group and aflibercept monotherapy group.
In the OZPRIME group after baseline evaluation, intra vitreal dexamethasone injection 0.7 mg will be done, followed by anti VEGF ranibizumab 0.5 mg intravitreal injection at 4th month. At 5th month, anti VEGF ranibizumab 0.5 mg intravitreal injection will be given unless stability criteria is achieved. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female Patients at least 18 years of age attending the outpatient clinic with NPDR and Diabetic macular edema in at least one eye during the study period will be randomly included after taking an informed consent.
2. Snellen Visual acuity (BCVA greater than 34 and lesser than 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters) |
|
| ExclusionCriteria |
| Details |
1. Glycated hemoglobin (HbA1c) more than 12 at baseline.
2. Intraocular pressure (IOP) more than 22 mmHg at screening or on day 1
3. A diagnosis of glaucoma or patients with glaucoma suspects
4. A history of laser treatment within 3 months prior to screening
5. Use of anti-VEGF treatment within 3 months prior to screening
6. Use of intravitreal Steroids within 6 months prior to screening
7. Patients who are not willing to participate in this study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of OZPRIME strategy in management of DME over a 24-week treatment period and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2mg) |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) To evaluate the mean change of Best corrected Visual acuity following OZPRIME strategy and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2 mg). |
24 weeks |
2) To evaluate the change in retinal thickness in Optical Coherence Tomography (OCT) after 24 weeks following OZPRIME strategy and compare with antiVEGF monotherapy regimes (Ranibizumab 0.5 mg biosimilar and Aflibercept 2 mg).
|
24 weeks |
3) To evaluate the number of injections required in eyes undergoing OZPRIME strategy and compare with anti VEGF monotherapy regimes (Ranibizumab 0.5 mg and Aflibercept 2mg).
|
24weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
28/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetic macular oedema is one of the leading cause of vision loss and blindness in patients with diabetes mellitus. Though anti VEGF agents have been hugely popular and the current treatment of choice for the treatment of centre involving diabetic macular oedema. The role of steroids particularly Ozurdex has been increasing. Though Anti VEGF studies have demonstrated improved visual and anatomical outcomes with well tolerated safety profiles, the major disadvantage has been frequent injection and prolonged treatment care. One strategy to offset his problem could be the addition of intravitreal steroids like Ozurdex along with anti VEGF therapy using a fixed strategy. Our study aims at comparing outcomes after a novel strategy called Ozprime strategy wherein ozurdex implantation in first month followed by antiVEGF injections at fourth and fifth month is compared with monthly antiVEGF injections for five months using Ranibizumab biosimilar and aflibercept over 24 weeks period. |