| CTRI Number |
CTRI/2025/09/095221 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two eye injections (Aflibercept and Dexamethasone implant) for patients with vision problems due to diabetes |
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Scientific Title of Study
|
COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE
IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA:
A RANDOMIZED CONTROLLED TRIAL’ |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KAUSHALENDRA SINGH |
| Designation |
PG RESIDENT OPHTHALMOLOGY |
| Affiliation |
COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA |
| Address |
DEPARTMENT OF OPHTHALMOLOGY,
COMMAND HOSPITAL,EASTERN COMMAND
ALIPORE,KOLKATA.
Kolkata WEST BENGAL 700027 India |
| Phone |
9906903777 |
| Fax |
|
| Email |
drkaushal9019@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR KAUSHALENDRA SINGH |
| Designation |
PG RESIDENT OPHTHALMOLOGY |
| Affiliation |
COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA |
| Address |
DEPARTMENT OF OPHTHALMOLOGY,
COMMAND HOSPITAL,EASTERN COMMAND
ALIPORE, KOLKATA.
Kolkata WEST BENGAL 700027 India |
| Phone |
9906903777 |
| Fax |
|
| Email |
drkaushal9019@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR KAUSHALENDRA SINGH |
| Designation |
PG RESIDENT OPHTHALMOLOGY |
| Affiliation |
COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA |
| Address |
DEPARTMENT OF OPHTHALMOLOGY,
COMMAND HOSPITAL,EASTERN COMMAND
ALOPORE, KOLKATA.
Kolkata WEST BENGAL 700027 India |
| Phone |
9906903777 |
| Fax |
|
| Email |
drkaushal9019@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
COMMAND HOSPITAL EASTERN COMMAND KOLKATA |
| Address |
COMMAND HOSPITAL EASTERN COMMAND KOLKATA ALIPORE KOLKATA 700027 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KAUSHALENDRA SINGH |
COMMAND HOSPITAL EASTERN COMMAND KOLKATA |
DEPARTMENT OF OPHTHALMOLOGY,
COMMAND HOSPITAL,EASTERN COMMAND
KOLKATA. Kolkata WEST BENGAL |
09906903777
drkaushal9019@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMAND HOSPITAL EASTERN COMMAND ALIPORE KOLKATA |
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: H36||Retinal disorders in diseases classified elsewhere, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE
IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA:
A RANDOMIZED CONTROLLED TRIAL |
•Group 1: Aflibercept Arm
Intravitreal Aflibercept 2 mg/0.05ml every 4 weeks for 3 loading doses.
•Group 2: Dexamethasone Implant Arm
A single Intravitreal Dexamethasone implant 0.7 mg
|
| Comparator Agent |
COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA: A RANDOMIZED CONTROLLED TRIAL |
•Group 2: Dexamethasone Implant Arm a single Intravitreal Dexamethasone implant 0.7 mg |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria- Male and female patients more than 18 years old with visual impairment due to naive-DME.
Patients with type 1 or type 2 diabetes mellitus and HbA1c of less than 10 percentage at screening
Baseline CST more than 300 µm on spectral-domain OCT.
BCVA between 20/40(6/12) and 20/320(6/96) (ETDRS letters 70 to 25).
Hemoglobin A1c less than 10 percentage
Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study
|
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| ExclusionCriteria |
| Details |
Exclusion criteria
Patients with HbA1C more than 10 mg percentage or those who did not have stable control of diabetes since the last 3 months.
Patients with a history of vitrectomy, cataract leading to poor imaging, intra-ocular surgery within 3 months of enrollment into the study, aphakia, epiretinal membrane, vitreomacular traction.
Patient with uncontrolled hypertension (defined as a systolic blood pressure more than 160 mm Hg or a diastolic blood pressure more than 95 mm Hg)
Patient with history of cerebrovascular accident or myocardial infarction within 6 months, renal failure requiring dialysis or renal transplant, or other retinal vascular diseases
Patient with existing or suspected ocular or periocular infection in the study eye.
Patient with an existing intraocular inflammation (IOI).
Patient with uncontrolled glaucoma (defined as intraocular pressure more than 25 mmHg despite treatment with anti-glaucoma medication,) or according to Investigator’s judgment.
Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye
Use of dexamethasone intravitreal implant (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) in study eye at any time.
Laser photocoagulation (focal/grid or pan retinal) in the study eye during the 3-month period prior to baseline
Intraocular surgery including YAG laser in the study eye during the 3-month period prior to baseline
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG pregnancy test
Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
Proliferative diabetic retinopathy requiring Pan retinal photocoagulation (PRP)
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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On-site computer system |
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Blinding/Masking
|
Double Blind Double Dummy |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare the efficacy of intravitreal Aflibercept and intravitreal Dexamethasone implant in improving best-corrected visual acuity (BCVA) in treatment-naive DME patients |
Post Operative day-1,04TH WEEK,08TH WEEK,12TH WEEK THAN ONCE IN MONTH UP TO 06 MONTH |
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Secondary Outcome
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| Outcome |
TimePoints |
a)Safety profile (adverse events, intraocular pressure rise, cataract progression).
b)Rescue therapy response rate in non-responders.
c)Change in central macular thickness (CMT) on OCT.
d)Need for additional interventions (repeat dexamethasone, additional anti-VEG, laser)
|
POD-1,04TH WEEK,08TH WEEK,12TH WEEK THAN ONCE IN MONTH UP TO 06 MONTH |
|
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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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
|
Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetic retinopathy. The pathophysiology of DME involves multiple mechanisms, including vascular endothelial growth factor (VEGF) overexpression and chronic inflammation. Two major pharmacologic approaches are widely used for DME management: Anti-VEGF Therapy (Aflibercept) Aflibercept is a recombinant fusion protein that binds VEGF-A, VEGF-B, and placental growth factor (PlGF), thereby inhibiting neovascularization and vascular leakage. It has been established as a first-line therapy for center-involving DME due to its proven efficacy in improving visual acuity (BCVA) and reducing central macular thickness (CMT).
However, frequent injections (every 4-8 weeks) are required to maintain efficacy, leading to increased treatment burden and patient non-compliance. 2 Corticosteroid Therapy (Dexamethasone Implant - Ozurdex) The dexamethasone intravitreal implant (Ozurdex) provides sustained-release corticosteroid therapy, targeting the inflammatory component of DME. It reduces cytokine-mediated vascular permeability and stabilizes the blood- retinal barrier. Compared to anti-VEGF agents, Ozurdex has a longer duration of action, potentially reducing the number of injections required .However, side effects such as intraocular pressure (IOP) elevation and cataract progression are concerns, especially in phakic patients. In DME, intravitreal corticosteroids, been traditionally used as second-line treatment, due to the risk of intraocular pressure increase and cataract-related adverse events. However, attention has recently been focused on the primary or early use of intravitreal corticosteroids, due to growing evidence of the crucial role of inflammation in the pathogenesis of DME. Furthermore, intravitreal steroid implants offer the additional advantage of a longer duration of action compared to anti-vascular endothelial growth factor agents (anti-VEGF). |